Factor X Deficiency

ATLANTA, Sept. 11, 2024 /PRNewswire/ -- Kedrion Biopharma Inc. is excited to announce its sponsorship of the National Bleeding Disorders Foundation's (NBDF) 76th Annual Bleeding Disorders Conference (BDC) in Atlanta, Georgia. The event will take place from September 12-14, 2024, and will bring together individuals with bleeding disorders, their families, healthcare professionals, and researchers from across the country. Kedrion's sponsorship of the NBDF underscores the company's commitment to supporting the bleeding disorders community. Kedrion is a leading manufacturer of coagulation and rare disease therapies and is dedicated to providing patients with access to innovative treatments. The NBDF Conference is a unique opportunity for attendees to learn about the latest advancements in bleeding and clotting disorders research and treatment, connect with other individuals and families affected by these conditions, and gain valuable insights from experts in the field. The conference will feature a wide range of educational sessions, workshops, and networking opportunities, covering topics such as: Treatment options and advancements: Attendees will have the chance to learn about the latest developments in treatment options for various bleeding and clotting disorders, including new therapies and clinical trials. Living with a bleeding and or clotting disorder: The conference will address the challenges and opportunities associated with living with a diagnosis, including managing symptoms, navigating healthcare systems, and building support networks. Research and advocacy: Attendees will gain insights into ongoing research efforts and advocacy initiatives aimed at improving the lives of individuals with such disorders. Kedrion will be actively involved in the NBDF Conference, hosting several events and activities designed to engage with attendees and share information about its therapies. Highlights will be a Campfire presentation on the results of the Hereditary Factor X in Americas survey, the 2nd Annual Plasminogen Deficiency Roundtable and The Ultra Rare Networking Hour, a dedicated space for individuals with ultra-rare bleeding and or clotting disorders and their support network to connect and build relationships. This initiative will foster a sense of community and provide a platform for sharing experiences and resources. The NBDF Conference is also a valuable opportunity for Kedrion to connect with individuals living with Plasminogen Deficiency Type 1(PLGD-1), as well as patients with Hereditary Factor X Deficiency (HFXD), two rare and potentially life-threatening disorders. The company will be sharing information about the therapy developments in these areas and its ongoing research efforts. "At Kedrion, every employee is united by a powerful mission: to amplify the voices of patients with rare diseases and to continually improve their journey and care. Together, our global commitment ensures that every step forward is a step towards a brighter, more hopeful future" said Bob Rossilli, CCO, Global Business and US General Manager of Kedrion. Kedrion's participation in the NBDC reflects the company's commitment to improving the lives of individuals with rare diseases. By providing support, education, and access to innovative therapies, Kedrion is working to ensure that patients have the resources they need to live full and healthy lives. To learn more about the NBDF's 76th Annual Bleeding Disorders Conference, please visit National Bleeding Disorders Foundation, formerly NHF | NBDF. Contact: Jennifer Bayliss / [email protected] / 213-703-9604 SOURCE Kedrion Biopharma WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Distribution resumes of first and only medicine to treat plasminogen deficiency type 1 FORT LEE, N.J., April 29, 2024 /PRNewswire/ -- Kedrion Biopharma Inc., an international biopharmaceutical company specializing in the research and development, production, and commercialization of plasma-derived therapeutic products used in treating rare and serious diseases, announced today that plasminogen deficiency type 1 (PLGD-1) patients in the U.S. now have access to RYPLAZIM® (plasminogen, human-tvmh). RYPLAZIM® is the first and only FDA-approved treatment for the approximately 500 people in the U.S. affected by plasminogen deficiency type 1 (PLGD-1). PLGD-1 is an ultra-rare disease that leads to reduced plasminogen activity levels in the body, often resulting in fibrinous lesions on various organs. About 81% of the patients develop lesions on one or both eyes as their lead symptom, but lesions can develop throughout the body on all organs with mucous membranes. Patients with PLGD-1 may require lifelong treatment. "RYPLAZIM® brings hope and relief to PLGD-1 patients of all ages who have long awaited effective treatment options," said Bob Rossilli, Chief Commercial Officer, Global Business of Kedrion Biopharma. "We are expediting production and distribution to patients and are proud to provide adult and pediatric patients with the first and only FDA-approved treatment designed specifically to address plasminogen deficiency." The FDA's clearance of RYPLAZIM® sets the stage for Kedrion to pursue additional regulatory approvals in other countries worldwide. It is the latest example of the company's commitment to expanding access to life-changing drugs to rare disease patients globally. To learn more about RYPLAZIM® and PLGD-1, please visit: ryplazim.com or plasminogen.com About Kedrion Kedrion Biopharma is an international biopharmaceutical company specializing in the research and development, production, and commercialization of plasma-derived therapeutic products for use in treating and preventing serious diseases, disorders, and conditions like plasminogen deficiency, hereditary factor X deficiency, and hemophilia. Its portfolio of 37 life-saving products is distributed in over 100 countries. Contact Sandy Sklareski Communications Manager, North America and LATAM [email protected] 551-255-6557 APPROVED USE RYPLAZIM® (plasminogen, human-tvmh) is plasma-derived human plasminogen indicated for the treatment of patients with plasminogen deficiency type 1 (hypoplasminogenemia). IMPORTANT SAFETY INFORMATION RYPLAZIM is contraindicated in patients with known hypersensitivity to plasminogen or other components of RYPLAZIM. Do not take RYPLAZIM if you have had a severe reaction to RYPLAZIM or another product containing plasminogen. Tell your healthcare provider about all of your medical conditions, including any medicines you take, including prescription and non-prescription medicines, such as over-the-counter medicines, supplements or herbal remedies. RYPLAZIM may worsen or prolong ongoing bleeding. In addition, if you have abnormal tissue growths because of your low plasminogen level, then you may have bleeding as these growths heal in response to treatment with RYPLAZIM. If you vomit blood, have blood from your rectum or black tarry stools or any bleeding that is heavy or does not resolve after 30 minutes of direct pressure seek emergency care and discontinue further use of RYPLAZIM. As your lesions heal then they will fall off, known as tissue sloughing, this is in response to treatment with RYPLAZIM. This is also a normal response and is not a side effect. Specific examples: If you have tissue growths in your airway or lungs you may cough up small amounts of tissue and you may cough up a small amount of blood or blood clots. If you have tissue growths in your genitourinary system, then you may pass tissue or blood clots in your urine or from your penis or vagina. If you have tissue growths in your gastrointestinal system you may have some tissue or blood clots in your stool or you may vomit blood or blood clots. If you have eye lesions you may have oozing of blood from the lesions in your eye. Notify your healthcare provider if you develop breathing difficulty, wheezing, cough, changes in speech, or pain in the back, abdomen, groin, or pelvic area, because these could be symptoms of tissue from resolving lesions that are obstructing the lungs, the kidneys, the bladder, the uterus and/or vagina, or the intestines. RYPLAZIM is made from human plasma and therefore carries a risk of transmitting infectious agents, e.g., viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent, and theoretically, the Creutzfeldt-Jakob Disease (CJD) agent. You may have an allergic reaction while taking RYPLAZIM. Stop treatment and contact your healthcare provider immediately if you develop trouble breathing, wheezing, chest tightness, light headedness, dizziness, swelling in the face or throat, itching, a rash, or hives. Your body may make antibodies against RYPLAZIM that may stop RYPLAZIM from working properly. Your healthcare provider will monitor you periodically for lesions which may be due to a low plasminogen level. If you develop new lesions or a recurrence of a previous lesion, then your healthcare provider will obtain blood to test for plasminogen activity level. In clinical trials, the most common (incidence ≥ 10%) side effects associated with the infusion of RYPLAZIM were abdominal pain, bloating, nausea, fatigue, extremity pain, hemorrhage, constipation, dry mouth, headache, dizziness, arthralgia, and back pain. Female patients who are pregnant or may become pregnant should be aware that the potential effects of RYPLAZIM on pregnancy and breastfeeding are unknown. They should notify their physicians if they become or intend to become pregnant, or if they plan to breastfeed. Other side effects are possible. Speak with your healthcare provider about any side effects that do not go away or bother you. You are encouraged to report negative side effects of prescription drugs to the FDA. Call 1-800-FDA-1088 or . For more details, please see full Prescribing Information. SOURCE Kedrion Biopharma

Global biopharma company encourages education and awareness around a rare bleeding disorder. FORT LEE, N.J., Oct. 10, 2023 /PRNewswire/ -- Kedrion Biopharma, an international biopharmaceutical company specializing in the production and distribution of plasma-derived therapeutic products used in treating rare and serious diseases, is proud to recognize the fourth Hereditary Factor X (10) Deficiency Awareness Day on October 10, 2023. This day helps bring awareness to a rare bleeding disorder, the patients it impacts, their challenges, and the treatments that can help. Continue Reading Factor X Day was launched on 10/1020 by U.K.-based Bio Products Laboratory (BPL). In 2022, Kedrion joined forces with BPL. The new Kedrion is a global player in plasma derivatives and rare disease medicines, employing more than 5,000 people worldwide. Kedrion Biopharma is proud to recognize the fourth Hereditary Factor X (10) Deficiency Awareness Day on October 10, 2023 Tweet this About one in a million people have hereditary factor X deficiency, which causes unusual or excessive bleeding or bruising, heavy menstrual bleeding in women, painful or swollen joints, nose bleeds, and bleeding gums. Although the disorder is ultra-rare, some patients with severe factor X deficiency could experience life-threatening complications like bleeding in the brain or stomach. Because symptoms vary, patients may suffer for years before being diagnosed. A simple blood test can determine whether someone has the disorder and can be treated with plasma-based treatments. John, one of the oldest known patients with severe hereditary factor X deficiency at age 51, says it best. "Since being diagnosed when I was a year old, I have had to go to the hospital about 150 times for transfusions of fresh frozen plasma to treat bleeds that were not controlled by themselves. As someone living with hereditary factor X deficiency, I want everyone to be more aware of this rare disease and why it is so important to get care and treatment." "We are excited for the first Hereditary Factor X Deficiency Awareness Day since Kedrion joined forces with Bio Products Laboratory in 2022," said Bob Rossilli, Chief Commercial Officer for Kedrion Biopharma. "With over 60 years of combined expertise across the United Kingdom, United States, and Italy, we are delighted to continue raising awareness for hereditary factor X deficiency and providing therapies to support patients, their caregivers, and families on the journey from diagnosis to treatment." Kedrion is committed to providing therapies for rare diseases to improve patients' health as they manage bleeding disorders like hereditary factor X deficiency. To learn more about hereditary factor X deficiency, visit . About Kedrion Kedrion Biopharma is a global biopharmaceutical company that collects and fractionates blood plasma to produce and distribute plasma-derived therapies for use in treating and preventing serious diseases, disorders, and conditions like plasminogen deficiency, hereditary factor X deficiency, and hemophilia. Its portfolio of 37 life-saving products is distributed in over 100 countries. kedrion.com Contact Information: Sandy Sklareski Communications Manager [email protected] 551-255-6557 SOURCE Kedrion Biopharma