In this study, researchers will observe and study the data from participants with hemophilia A who receive damoctocog alfa pegol as prescribed by their doctors. Participants will not receive any advice or changes to their healthcare during the study.
Hemophilia A is a genetic bleeding disorder. It is caused by the lack of a protein called clotting factor 8 (FVIII) that helps blood to clot properly. Lack of FVIII can result in excessive blood loss or bleeding inside the body after being injured or having surgery.
The study drug, damoctocog alfa pegol, can be used to prevent or treat bleeding episodes by replacing missing FVIII in the body of people with hemophilia A. It is already approved for people with hemophilia A who are at least 12 years old and have previously used other hemophilia A treatments.
Through this study, researchers want to learn more about its safety in a real-world setting.
The participants will receive damoctocog alfa pegol as prescribed by their doctors during routine practice according to the approved product information.
The main purpose of this study is to learn more about how safe damoctocog alfa pegol is in Korean participants with hemophilia A who previously used other hemophilia A treatments. To do this, researchers will collect information about any medical problems participants have during their treatment.
Data will be collected from December 2023 to March 2026 and cover a period of about 8 months for each participant. Data will come from participants' health records and information collected during their routine clinic visits.
In this study, only available data from routine care will be collected. No visits or tests are required as part of this study.

Start Date24 Jan 2024

Sponsor / Collaborator

Bayer AG

NCT05643560

/ RecruitingNot Applicable

Long-term Treatment Outcome of Jivi® Prophylaxis on Joint Health in Adult Patients With Hemophilia A

This is an observational study in which data from people with hemophilia A who decide on their own or by recommendation of their doctors to take Jivi are collected and studied. In observational studies, only observations are made without specified advice or interventions.
Hemophilia A is a genetic bleeding disorder that is caused by the lack of a protein in the blood called "clotting factor 8" (FVIII). FVIII is naturally found in the blood where it causes the blood to clump together to help prevent and stop bleeding. People with lower levels of FVIII or with FVIII that does not work properly may bleed for a long time from minor wounds, have painful bleeding into joints, or have internal bleeding.
The study treatment, Jivi (also called damoctocog alfa pegol), is already available for doctors to prescribe to people with hemophilia A to treat and prevent bleeding. It works by replacing the missing FVIII, or the FVIII that does not work properly.
People with hemophilia A need frequent injections of FVIII products into the vein. So called standard half-life (SHL) products need to be given 2 to 4 times a week for the prevention of bleeding. In recent years, new products like Jivi called extended half-life (EHL) products have available. These products last longer in the body so that they require to be given less often with injections up to every 7 days. Thus, these treatments may be easier and more comfortable to stick to in daily life. There is no general plan concerning the best amount of treatment and the frequency of injections for the prevention of bleeding, since the severity may be different and individual risk factors have to be considered. Doctors often decide on a treatment plan based on patient's disease and response.
Clinical studies have already shown that people with hemophilia A benefit from the treatment with Jivi. However, there are no data available coming from the real-world about how well Jivi works to support joint health, measured by ultrasound (US) examination and HEAD-US score.
In this study, researchers want to learn more about how well Jivi works if used for prolonged periods of treatment under real-world settings to prevent problems with joints in people with hemophilia A. How well it works means to find out if participants' joints status can be improved by treatment with Jivi.
To do this, researchers will collect data about participants' joints status by
* making images of participants' joints by using sound waves (ultrasound), and
* using HEAD-US score after 24 months of treatment with Jivi. The researchers will then compare these data to the participants' joints status before treatment start with Jivi.
Besides this data collection, no further tests or examinations are planned in this study.
Some participants in this study will already be receiving treatment with Jivi as part of their regular care no more than 12 months. And some participants will start to take Jivi in this study as prescribed by their doctors during routine practice according to the approved product information.
The researchers will collect data from each patient for a period of 26 months after initiation of the Jivi treatment.
There are no required visits or tests in this study

Start Date29 Dec 2022

Sponsor / Collaborator

Bayer AG

NCT05036278

/ CompletedPhase 4

A Multicenter, Prospective, Open-label, Clinical Study to Assess the Effect of Using a New Risk Score Approach to Select the Most Appropriate Prophylaxis Regimen for Reaching a Favorable Outcome, When Hemophilia A Patients Switch From Standard Half-life Products to Damoctocog Alfa Pegol (Jivi)

Researchers are looking for a better way to treat people who have hemophilia A. Hemophilia A is a genetic bleeding disorder that is caused by the lack of a protein in the blood called "clotting factor 8" (FVIII). FVIII is naturally found in the blood where it causes the blood to clump together to help prevent and stop bleeding. People with lower levels of FVIII or with FVIII that does not work properly may bleed for a long time from minor wounds, have painful bleeding into joints, or have internal bleeding.
The study treatment, Jivi (also called damoctocog alfa pegol), is already available for doctors to prescribe to people with hemophilia A to treat and prevent bleeding. It works by replacing the missing FVIII, or the FVIII that does not work properly.
People with hemophilia A need frequent injections of FVIII products into the vein. So called standard half-life (SHL) products need to be given 2 to 4 times a week for the prevention of bleeding. In recent years, new products like Jivi called extended half-life (EHL) products have become available. These products last longer in the body so that they require to be given less often with injections every 3-5 days. Thus, these treatments may be easier and more comfortable to stick to in daily life. There is no general plan concerning the best amount of treatment and the frequency of injections for the prevention of bleeding, since the severity may be different and individual risk factors have to be considered. Doctors often decide on a treatment plan based on their experience.
The main purpose of this study is to learn how well a new scoring approach works to select a treatment plan for the prevention of bleeding in people with hemophilia A who switch their treatment from SHL products to Jivi. Different types of information are used to calculate the risk score like bleeding history, certain biological factors, and physical activity of the participant.
All participants will receive Jivi for 6 months.
In the first four weeks, all participants will receive Jivi 2 times a week at a dose level of 40 IU per kilogram body weight (also known as 40 IU/kg/dose, recommended maximum dose is 6,000 IU). Then, based on their risk score, each participant will be assigned to one of three treatment plans:
* participants with a high risk remain on Jivi administration 2 times a week at 40 IU/kg/dose
* participants with a medium risk will switch to Jivi administration every 5 days at 50 IU/kg/dose
* participants with a low risk will switch to Jivi administration every 5 days at 50 IU/kg/dose and after 4 weeks to a less frequent administration (e.g., every 7 days) at 60 IU/kg/dose To check how well the new scoring approach works for choosing the right treatment plan, researchers will look at how many participants have a favourable outcome.
This means that the participant has either fewer bleeding events vs. the pre-study treatment and takes Jivi less often or as often as the previous SHL treatment but with fewer bleeding events, or that the participant has a comparable number of bleeding events but needs to take Jivi less often than the previous treatment. Each participant will be in the study for approximately 7.5 months. During this time, 4 visits to the study site and 3 phone calls are planned. During the study, the doctors and their study team will: • do physical examinations • take blood samples • ask the participants questions about how they are feeling and what adverse events they are having. In addition, participants or their guardians are required to write down the dates of Jivi treatments and bleeding events in an electronic diary and to fill in different questionnaires on their quality of life, health status, work/ school productivity, pain, and treatment satisfaction. In addition, participants are expected to keep appointments for visits and to adhere to the assigned treatment regimen.
An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments.

Start Date28 Jul 2022

Sponsor / Collaborator

Bayer AG

100 Clinical Results associated with Damoctocog Alfa Pegol

100 Translational Medicine associated with Damoctocog Alfa Pegol

100 Patents (Medical) associated with Damoctocog Alfa Pegol

Literatures (Medical) associated with Damoctocog Alfa Pegol

01 Mar 2025·EUROPEAN JOURNAL OF HAEMATOLOGY

Effectiveness of Damoctocog Alfa Pegol to Treat Patients With Hemophilia A Enrolled in the ATHNdataset

Article

Author: Recht, Michael ; Charlet, Jessica ; Moulton, Thomas ; Charafi, Lena ; Chandler, Martin

ABSTRACT:

Objectives:

Health information for 17 109 people living with hemophilia A (PLwHA) is contained within the ATHNdataset. We aimed to evaluate the real‐world effectiveness of damoctocog alfa pegol (BAY 94‐9027, Jivi®) for hemophilia A.

Methods:

The ATHNdataset was queried for PLwHA receiving damoctocog alfa pegol between January 1, 2010 and April 30, 2022. Data captured via patient charts were analyzed.

Results:

At data cutoff, 205 PLwHA were treated with damoctocog alfa pegol: 150 (73.2%) severe (1 female [0.5%]) and 55 (26.8%) mild/moderate (3 [1.5%] female). In total, 32/205 (25.9%) PLwHA received on‐demand treatment; 172 (83.9%) received prophylaxis—161 (93.6%) continuous prophylaxis. Documented bleed rates were available for 187 (91.2%) PLwHA, including those on prophylaxis and on‐demand regimens, with 150 (80.2%) treated for > 12 months. Overall annualized bleeding rates and proportion of PLwHA with zero bleeds, receiving prophylaxis during the observation period, were mean (SD) 0.26 (1.03) and 138/157 (87.9%), respectively. No new or recurring inhibitors were reported.

Conclusion:

A low number of bleeds were observed with damoctocog alfa pegol in the real world in both male and female PLwHA. Data should be interpreted with caution owing to limitations of real‐world studies and insubstantial data for female PLwHA.

01 Jan 2025·ADVANCES IN THERAPY

Efanesoctocog Alfa versus Standard and Extended Half-Life Factor VIII Prophylaxis in Adolescent and Adult Patients with Haemophilia A without Inhibitors

Review

Author: Klamroth, Robert ; Kragh, Nana ; Wojciechowski, Piotr ; Margas, Wojciech ; Bystrická, Linda ; Arnaud, Alix ; Wdowiak, Marlena ; Guyot, Patricia ; Wilson, Amanda ; Tosetto, Alberto

INTRODUCTION:

In the Phase 3 XTEND-1 trial, (NCT04161495) efanesoctocog alfa prophylaxis provided superior bleed protection versus pre-study factor VIII (FVIII) replacement therapy in patients with severe haemophilia A. The aim of this study was to indirectly compare bleed outcomes between efanesoctocog alfa and standard/extended half-life (SHL and EHL) FVIII replacement therapies in adolescent and adult patients with severe haemophilia A without inhibitors.

METHODS:

A systematic literature review was conducted to identify Phase 3 trials of EHL and SHL FVIII replacement therapies for comparison with efanesoctocog alfa data from XTEND-1. Matching-adjusted indirect comparisons were used to compare annualised bleeding rates (ABRs) for any, treated, joint, and spontaneous bleeds between efanesoctocog alfa and comparators. The estimates from respective comparisons were pooled using random-effect meta-analyses to evaluate the overall difference between efanesoctocog alfa and comparator therapies.

RESULTS:

Four EHL therapies (rurioctocog alfa pegol, efmoroctocog alfa, turoctocog alfa pegol, damoctocog alfa pegol) and two octocog alfa SHL therapies were included. In meta-analyses, efanesoctocog alfa was associated with significantly lower ABRs for any [mean difference (95% CI) - 2.24 ( - 3.24; - 1.25)], spontaneous [ - 1.52 ( - 2.33; - 0.72)], and joint bleeds [ - 1.60 ( - 2.32; - 0.88)] versus EHL therapies, and with significantly lower ABRs for any [ - 3.61 ( - 4.43; - 2.79)], treated [ - 1.55 ( - 1.89; - 1.20)], spontaneous [ - 2.52 ( - 3.31; - 1.72)], and joint bleeds [ - 3.42 ( - 4.77; - 2.08)] versus SHL therapies.

CONCLUSION:

Efanesoctocog alfa was associated with significantly lower ABRs (any, spontaneous and joint) compared with EHL or SHL prophylaxis therapies. Patients had, on average, 2.2 and 3.6 fewer bleeds per year versus EHL and SHL therapies, respectively.

01 Dec 2024·Blood Research

Real-world insights into the management of hemophilia A in Italy: treatment patterns and healthcare resource utilization

Article

Author: Cappuccilli, Maria ; Leogrande, Melania ; Perrone, Valentina ; Esposti, Luca Degli

Abstract:

Purpose:

This real-world analysis described the Hemophilia A (HA) population in Italy, evaluating drug utilization and consumption of factor VIII (FVIII) products of patients under prophylaxis and on-demand therapy.

Methods:

From Jan-2017 to Jun-2022, male patients with HA were identified through prescriptions of FVIII products [extended half-life FVIII, standard half-life recombinant FVIII, and plasma-derived FVIII (EHL FVIII, SHL rFVIII, and pdFVIII, respectively)], or emicizumab or FVIII plus von Willebrand factor or HA-related hospitalization using administrative flows of Italian healthcare entities. Patients on treatment with FVIII products during 2021–2022 were stratified by treatment regimen (prophylaxis/on-demand). The mean annual consumption expressed in International Units (IU) of EHL FVIII and SHL FVIII in patients treated during 2021–2022 having at least 12-month follow-up were assessed.

Results:

Among included HA patients, 145 (39.5%) received EHL FVIII and 222 (60.5%) SHL FVIII. Of 165 patients on prophylaxis, 105 (64%) received an EHL FVIII and 60 (36%) an SHL FVIII. The mean annual consumption of FVIII was 336,700 IU (median 319,000 IU) for EHL FVIII and 440,267 IU (median 360,500 IU) for SHL FVIII. Specifically, for patients on EHL FVIII, the most common drugs were efmoroctocog alfa (N = 51) and damoctocog alfa pegol (N = 50), followed by turoctocog alfa pegol (N = 25) and rurioctocog alfa pegol (N = 19). Of 702 HA patients initially treated with FVIII products, 74 (10.5%) switched to emicizumab during follow-up.

Conclusion:

These findings revealed an extensive use of EHL FVIII products, suggesting growing efforts from clinicians to optimize prophylactic strategies and achieve better bleeding protection.

News (Medical) associated with Damoctocog Alfa Pegol

29 Feb 2024

·www.biospace.com

Baisong Mei’s Immigrant Journey Through American Biopharma

Pictured: Baisong Mei/Nicole Bean for BioSpace Baisong Mei is no stranger to leadership roles. At just 15 years old, he was already in medical school leading a group of students 10 years his senior. (In China, medical students skip undergraduate degrees and instead go straight to a doctoral program.) That was just one of many instances of leadership peppered throughout the career of Editas’s current chief medical officer. Mei was born in a small town in the southern part of Anhui province in China. He skipped grades a couple of times, which allowed him to start college at Bengbu Medical College (now Bengbu Medical University) at just 15 years old, the first time in his life he went to a bigger city, Bengbu. Because he had done well in high school, scored reasonably well on the college entrance examination, held leadership positions and participated in competitions, he was made the head of a group in the class. This entailed leading older students in group activities, an experience he called “challenging.” But that didn’t discourage him. After graduating from Bengbu Medical College at the age of 20, he went on to earn a master’s degree at Wuhan University School of Medicine, where he then worked as a faculty member for five years. At 28, he left China to move to Ohio with only two suitcases. There, Mei earned a Ph.D. in molecular biology and biochemistry from the University of Toledo. He then completed fellowships at the University of California, San Francisco and UC Berkeley; held leadership positions at Bayer, Biogen and Sanofi; and co-invented an approved drug, Jivi, an injectable medicine from Bayer for people with hemophilia A. Mei’s laundry list of accomplishments goes on. But he said that one of the most rewarding successes of his career is seeing patients in clinical trials that he runs sign on for an extension. He explained that this usually means patients feel like the drug is working for them without too many complications, which is a huge success in the R&D world. It’s happened many times throughout his career, he said, the first time with a hemophilia B drug at Biogen that was later approved by the FDA and marketed as Alprolix. Learning to Adapt Mei’s position at early-stage biotech Editas is more entrepreneurial than his earlier career, allowing him to remain close to the science and to clinical trials. But after coming from academia and Big Pharma, learning how to operate in a genome editing biotech with a few hundred employees involves a learning curve, he said. Fortunately for him, his formula for success is all about continuously learning and adapting. The most valuable thing he’s learned since starting at Editas in 2022 is how to communicate in a way that inspires confidence in the company, he said, so that stakeholders know that it has a solid strategy and can deliver helpful products. He’s been part of the executive leadership team working to transform Editas from a technology platform company to a commercial therapeutics company and leader in in vivo programmable gene editing. The team made changes to sharpen the company’s strategic focus and emphasize execution of clinical programs. “When you become a CMO in a private company, in addition to driving all these clinical trials, you also [have to think about] how the company can grow and what is the strategy of the company so that [it] can help more patients and help the stakeholders of the company,” he said. With these additional responsibilities, “I feel that I’m able to make more impact, not only to the company, [but] to the patients.” Mei categorizes the challenges he’s encountered in his career into two types: cultural and career-related. Most of his cultural challenges happened when he first came to the U.S. and had to adapt to food, language, TV, interpersonal interactions and many other aspects of daily life that were completely different from China. And his cultural environment has varied greatly even throughout his time in the U.S., he said, since he’s now lived in the Midwest and on both coasts. “The education system in China really . . . set a foundation for me to be able to adapt here in United States,” he said, by emphasizing math, physics and chemistry, and putting a lot of value on hard work and discipline. For example, in high school, he often studied past midnight and in medical school he had over 30 hours of classes each week. “This allowed me to really focus on learning and be humble, and that really helped me a lot.” When he first came to the U.S. for his Ph.D., it was uncertain whether he would be able to remain in the country to work after his student visa period. So he viewed it as an experiment, completing his Ph.D. without knowing how the rest of his career would turn out. If he couldn’t stay in the U.S., his backup plan was to bring his learning back to China. “And now, of course, after more than 30 years, I feel I’m American,” he said. “I feel the United States has given immigrants like myself so many opportunities. I feel so grateful for that . . . this is actually an amazing place [that] can provide people opportunity. And I understand why many people want to come.” Mollie Barnes is a freelance science writer based in Los Angeles. Reach her at mollie@100yearsco.com. Follow her on Threads and Instagram @shejustlikedtogo and see more of her work at molliebarnes.contently.com.

Drug ApprovalExecutive Change

27 Feb 2024

·www.biospace.com

Baisong Mei’s Immigrant Journey Through American Biopharma

Pictured: Baisong Mei/Nicole Bean for BioSpace From entering college in China at just 15 to co-inventing a drug for Bayer, Mei’s career journey has been far from average. Now CMO at Editas, he’s not done yet. Pictured: Baisong Mei/Nicole Bean for BioSpace Baisong Mei is no stranger to leadership roles. At just 15 years old, he was already in medical school leading a group of students 10 years his senior. (In China, medical students skip undergraduate degrees and instead go straight to a doctoral program.) That was just one of many instances of leadership peppered throughout the career of Editas ’s current chief medical officer. Mei was born in a small town in the southern part of Anhui province in China. He skipped grades a couple of times, which allowed him to start college at Bengbu Medical College (now Bengbu Medical University) at just 15 years old, the first time in his life he went to a bigger city, Bengbu. Because he had done well in high school, scored reasonably well on the college entrance examination, held leadership positions and participated in competitions, he was made the head of a group in the class. This entailed leading older students in group activities, an experience he called “challenging.” But that didn’t discourage him. After graduating from Bengbu Medical College at the age of 20, he went on to earn a master’s degree at Wuhan University School of Medicine, where he then worked as a faculty member for five years. At 28, he left China to move to Ohio with only two suitcases. There, Mei earned a Ph.D. in molecular biology and biochemistry from the University of Toledo. He then completed fellowships at the University of California, San Francisco and UC Berkeley; held leadership positions at Bayer, Biogen and Sanofi; and co-invented an approved drug, Jivi, an injectable medicine from Bayer for people with hemophilia A. Mei’s laundry list of accomplishments goes on. But he said that one of the most rewarding successes of his career is seeing patients in clinical trials that he runs sign on for an extension. He explained that this usually means patients feel like the drug is working for them without too many complications, which is a huge success in the R&D world. It’s happened many times throughout his career, he said, the first time with a hemophilia B drug at Biogen that was later approved by the FDA and marketed as Alprolix. Learning to Adapt Mei’s position at early-stage biotech Editas is more entrepreneurial than his earlier career, allowing him to remain close to the science and to clinical trials. But after coming from academia and Big Pharma, learning how to operate in a genome editing biotech with a few hundred employees involves a learning curve, he said. Fortunately for him, his formula for success is all about continuously learning and adapting. The most valuable thing he’s learned since starting at Editas in 2022 is how to communicate in a way that inspires confidence in the company, he said, so that stakeholders know that it has a solid strategy and can deliver helpful products. He’s been part of the executive leadership team working to transform Editas from a technology platform company to a commercial therapeutics company and leader in in vivo programmable gene editing. The team made changes to sharpen the company’s strategic focus and emphasize execution of clinical programs. “When you become a CMO in a biotech company, in addition to driving all these clinical trials, you also [have to think about] how the company can grow and what is the strategy of the company so that [it] can help more patients and help the stakeholders of the company,” he said. With these additional responsibilities, “I feel that I’m able to make more impact, not only to the company, [but] to the patients.” Mei categorizes the challenges he’s encountered in his career into two types: cultural and career-related. Most of his cultural challenges happened when he first came to the U.S. and had to adapt to food, language, TV, interpersonal interactions and many other aspects of daily life that were completely different from China. And his cultural environment has varied greatly even throughout his time in the U.S., he said, since he’s now lived in the Midwest and on both coasts. “The education system in China really . . . set a foundation for me to be able to adapt here in United States,” he said, by emphasizing math, physics and chemistry, and putting a lot of value on hard work and discipline. For example, in high school, he often studied past midnight and in medical school he had over 30 hours of classes each week. “This allowed me to really focus on learning and be humble, and that really helped me a lot.” When he first came to the U.S. for his Ph.D., it was uncertain whether he would be able to remain in the country to work after his student visa period. So he viewed it as an experiment, completing his Ph.D. without knowing how the rest of his career would turn out. If he couldn’t stay in the U.S., his backup plan was to bring his learning back to China. “And now, of course, after more than 30 years, I feel I’m American,” he said. “I feel the United States has given immigrants like myself so many opportunities. I feel so grateful for that . . . this is actually an amazing place [that] can provide people opportunity. And I understand why many people want to come.” Mollie Barnes is a freelance science writer based in Los Angeles. Reach her at mollie@100yearsco.com . Follow her on Threads and Instagram @shejustlikedtogo and see more of her work at molliebarnes.contently.com . Correction (Feb. 29): This story has been updated to remove the mention that Editas is a private company; it is in fact a public company. BioSpace regrets the error.

Drug ApprovalExecutive Change

31 Oct 2023

·www.prnewswire.com

Octapharma AG: Indirect comparison data indicate that personalised prophylaxis with Nuwiq® may lead to fewer patients with haemophilia A having bleeds than with other recombinant factor VIII products

The well-established matching-adjusted indirect comparison (MAIC) methodology was used to compare the efficacy of personalised prophylaxis with Nuwiq® against other recombinant FVIII products Personalised prophylaxis with Nuwiq® can lead to higher rates of patients with zero bleeds compared with other recombinant FVIII products, albeit with higher weekly doses The data were published recently in the European Journal of Haematology LACHEN, Switzerland, Oct. 31, 2023 /PRNewswire/ -- Data from a matching-adjusted indirect comparison (MAIC) of Nuwiq® (simoctocog alfa) versus extended half-life recombinant factor VIII (rFVIII) concentrates in haemophilia A patients undergoing personalised prophylaxis were published in the European Journal of Haematology1. Preliminary data from the MAIC were presented by Dr Craig Kessler, Lombardi Comprehensive Cancer Center and Georgetown University Medical Center, at the 65th ASH Annual Meeting & Exposition in December 20222. Continue Reading Octapharma AG: Indirect comparison data indicate that personalised prophylaxis with Nuwiq® may lead to fewer patients with haemophilia A having bleeds than with other recombinant factor VIII products The analysis used MAIC – a well-established statistical approach – to compare the efficacy of pharmacokinetic (PK)-guided, personalised prophylaxis with Nuwiq® (simoctocog alfa) versus Eloctate® (efmoroctocog alfa), Jivi® (damoctocog alfa pegol), and Adynovate® (rurioctocog alfa pegol). The analysis used data from prospective clinical trials of personalised prophylaxis in adults with severe haemophilia A. Dr Kessler commented, "This MAIC exercise provides important comparative data on the efficacy and consumption of various recombinant FVIII products in adults with haemophilia A on personalised prophylaxis. The results can be considered by clinicians and patients when treatment decisions are being made." MAICs are a way of comparing the efficacy of different medical interventions or products in the absence of head-to-head randomised trials3. By matching patient populations based on clinically relevant baseline characteristics, it reduces inherent differences between the studies and can provide comparative evidence of relative treatment effects. Individual patient data from patients treated with Nuwiq® in the NuPreviq study were compared with aggregated data from 117 patients treated with Eloctate® in the personalised prophylaxis arm of the A-LONG study, 110 patients treated with Jivi® in the PROTECT VIII study, and patients treated with Adynovate® in the PROPEL study (which had two arms targeting different FVIII trough levels: 1–3% (57 patients) and 8–12% (58 patients)). A significantly higher percentage of patients with zero bleeds was reported with Nuwiq® compared with Eloctate® (75% vs 45%), Jivi® (77% vs 38%) or Adynovate® (target trough level 1–3%; 78% vs 42%). The efficacy of Nuwiq® was similar to that of Adynovate® in the 8–12% arm (77% vs 62%). The mean annualised bleeding rate was significantly lower with Nuwiq® than with Jivi® (1.5 vs 4.9). Consistent with the approved dosing, the mean FVIII weekly dose was significantly higher for Nuwiq® than Eloctate®, Jivi® or Adynovate® 1–3%, but lower than for Adynovate® 8–12%. Further details of the study can be found in the European Journal of Haematology publication. In addition, a short video summarising the results is available in the online version of the article. About Octapharma Headquartered in Lachen, Switzerland, Octapharma is one of the largest human protein manufacturers in the world, developing and producing human proteins from human plasma and human cell lines. Octapharma employs more than 11,000 people worldwide to support the treatment of patients in 118 countries with products across three therapeutic areas: Immunotherapy, Haematology and Critical Care. Octapharma has seven R&D sites and five state-of-the-art manufacturing facilities in Austria, France, Germany and Sweden, and operates more than 190 plasma donation centres across Europe and the US. Octapharma has 40 years of experience in patient care. About Nuwiq® Nuwiq® (simoctocog alfa) is a 4th generation recombinant factor VIII (rFVIII) protein, produced in a human cell line without chemical modification or fusion with any other protein4. It is cultured without additives of human or animal origin, is devoid of antigenic non-human protein epitopes and has a high affinity for von Willebrand factor4. Nuwiq® treatment has been assessed in nine4-6 completed clinical trials which included 201 previously treated patients (190 individuals)4 and 108 previously untreated patients5 with severe haemophilia A. Nuwiq® is available in 250 IU, 500 IU, 1,000 IU, 1,500 IU, 2,000 IU, 2,500 IU, 3,000 IU and 4,000 IU presentations7. Nuwiq® is approved for use in the treatment and prophylaxis of bleeding in patients with haemophilia A (congenital FVIII deficiency) across all age groups7. References Kessler CM et al. Eur J Haematol 2023; 111:757–67. Kessler CM and Tiede A. Blood 2022; 140(Suppl. 1): 2755–6. Signorovitch JE et al. Value Health 2012; 15:940–7. Lissitchkov T et al. Ther Adv Hematol 2019; 10:2040620719858471. Liesner RJ et al. Thromb Haemost 2021; 121:1400–8. Octapharma AG, data on file. Nuwiq® Summary of Product Characteristics. Logo - Video - SOURCE Octapharma AG

Clinical ResultDrug ApprovalClinical Study

100 Deals associated with Damoctocog Alfa Pegol

External Link

KEGG	Wiki	ATC	Drug Bank
D10759	Damoctocog Alfa Pegol	B02BD02	DB14700

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Hemophilia A	United States	Bayer Healthcare LLC	29 Aug 2018

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Hemorrhage	Phase 3	United States	Bayer AG	29 May 2013
Hemorrhage	Phase 3	Argentina	Bayer AG	29 May 2013
Hemorrhage	Phase 3	Austria	Bayer AG	29 May 2013
Hemorrhage	Phase 3	Belgium	Bayer AG	29 May 2013
Hemorrhage	Phase 3	Bulgaria	Bayer AG	29 May 2013
Hemorrhage	Phase 3	Canada	Bayer AG	29 May 2013
Hemorrhage	Phase 3	Greece	Bayer AG	29 May 2013
Hemorrhage	Phase 3	Israel	Bayer AG	29 May 2013
Hemorrhage	Phase 3	Italy	Bayer AG	29 May 2013
Hemorrhage	Phase 3	Lithuania	Bayer AG	29 May 2013

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04085458 (CTgov)	Phase 4	Hemophilia A	32	BAY94-9027	ezyfufyshp = qdptoywyuo gjnzrylcbt (oduvtjxpxz, lqyorncxzi - hpccpgmstv) View more	-	28 Jun 2023
ISTH2023	Not Applicable	-	10	Damoctocog alfa pegol	llgxuqvshq(rtorctsmcn) = zfjmctmbky hsejvykqvi (mcrzlgdvwt ) View more	-	24 Jun 2023
ISTH2023	Not Applicable	Hemophilia A	-	BAY 94-9027	wxkkmhiahz(girhnzubcc) = jpmcmcxixh ganxvacngf (yajcwvcnqw )	Positive	24 Jun 2023
				BAY 81-8973	wxkkmhiahz(girhnzubcc) = dzsuzthgxr ganxvacngf (yajcwvcnqw )
HEM-POWR Study (ISTH2022)	Not Applicable	Hemophilia A	162	Damoctocog alfa pegol	pkwcsyvgso(msrrutmjru) = brjfvubyay eerfyviiro (zfcvuswlht )	Positive	09 Jul 2022
ISTH2021	Not Applicable	Hemophilia A	134	BAY 94-9027	mwpqbhriqb(kjmjughbnb) = lcurpxzavb rrsxoleled (kjgnixdhtk )	Positive	17 Jul 2021
NCT04015492 (Pubmed \| Ann Hematol)	Phase 1	Hemophilia A	18	damoctocog alfa pegol	lbnchsmjxa(tyscyzkovq) = wlvrgljwdq tyjxmhktzr (aqsrzpmejn )	-	01 Nov 2020
				rurioctocog alfa pegol	lbnchsmjxa(tyscyzkovq) = xpszoaqizu tyjxmhktzr (aqsrzpmejn )
NCT01580293 (PROTECT VIII, ISTH2020)	Phase 2/3	Hemophilia A	121	BAY 94-9027	nguvdhcxri(oapznqmmom) = zuqbkafmlh ntwxhjszim (vlthqokpyg ) View more	-	12 Jul 2020
NCT01580293 (PROTECT VIII, ISTH2020)	Phase 2/3	Hemophilia A	114	BAY 94-9027 prophylaxis every 5 days	cjjbzdpcsk(pqphrfcgnk) = 5 (13.9%) patients experienced non-serious treatment-emergent drug-related adverse events nefuvkgggh (dcclynapnn )	Positive	12 Jul 2020
				BAY 94-9027 prophylaxis every 7 days
NCT01580293 (PROTECT-VIII, Pubmed \| J Thromb Haemost) Manual	Phase 2/3	Hemophilia A	132	BAY 94-9027 (every-5-days (45-60 IU kg-1 ))	wzacqlvghw(dqmyrifwab) = pxgozhmzrc yhtqfwigop (mueghhmyss )	Positive	01 Mar 2017
				BAY 94-9027 (every-7-days (60 IU kg-1 ))	wzacqlvghw(dqmyrifwab) = djdzovoepi yhtqfwigop (mueghhmyss )
NCT01184820 (Pubmed \| J Thromb Haemost)	Phase 1	Hemophilia A	14	BAY 94-9027	mrwcbtubbb(tlmafctcye) = dtxmexglhf jxyxddewkr (sojyaoxuqn )	-	01 Apr 2014
				sucrose-formulated rFVIII (rFVIII-FS)	mrwcbtubbb(tlmafctcye) = xhfnqzoczr jxyxddewkr (sojyaoxuqn )

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