Dabigatran Etexilate Mesylate

MAVIRET® (Glecaprevir/Pibrentasvir) is the Only Treatment Approved in the European Union for Both Acute and Chronic Hepatitis C Virus (HCV) Infection Approval Allows Providers to Treat HCV Patients Immediately at Time of Diagnosis; Early Diagnosis and Treatment Help Reduce Transmission, Long-Term Liver-Related Complications, and Support HCV Elimination Efforts Glecaprevir, One of the Two Direct-Acting Antivirals in MAVIRET ® , was Discovered by Enanta and Developed and Commercialized by AbbVie WATERTOWN, Mass.--(BUSINESS WIRE)-- Enanta Pharmaceuticals, Inc . (NASDAQ:ENTA), a clinical-stage biotechnology company dedicated to creating small molecule drugs for viral infections and immunological diseases, today announced that the European Commission has approved MAVIRET ® (glecaprevir/pibrentasvir), an oral pangenotypic direct-acting antiviral (DAA) therapy, for the treatment of acute HCV infection without cirrhosis or with compensated cirrhosis in adults and children aged 3 years and older. MAVIRET is now the only treatment approved in the European Union (EU) for both acute and chronic HCV infection. “The European Commission’s approval of MAVIRET for acute HCV infection is a meaningful step for the more than 12 million individuals in Europe living with HCV, by enabling earlier treatment and supporting timely intervention at a stage when the disease may be asymptomatic and can go undetected,” said Jay R. Luly, Ph.D., President and Chief Executive Officer at Enanta Pharmaceuticals. “Given acute HCV is typically diagnosed incidentally, starting treatment before a patient has advanced to chronic HCV can be difficult. Today’s approval supports public health efforts by accelerating treatment, reducing transmission and addressing unmet need. We take pride in the role our discovery of glecaprevir has played in bringing forward a therapy that continues to benefit HCV patients worldwide. We are pleased that AbbVie continues to collaborate with global regulatory authorities to support access to MAVIRET for people who have acute HCV infection.” The EU approval for acute HCV infection was supported by data from the Phase 3, multicenter, single-arm prospective study evaluating the safety and efficacy of MAVIRET eight-week treatment in patients with acute HCV infection. 1 The study results showed MAVIRET to be a highly efficacious treatment for people with acute HCV. 1 The majority of the adverse events reported were mild or moderate in severity. 1 The most common adverse events were fatigue, diarrhea, headache, and asthenia. 1 HCV is a highly infectious, blood-borne disease that affects the liver and if left untreated can lead to serious complications, including liver cirrhosis and cancer. 2 Acute HCV infection is frequently asymptomatic and many people remain unaware of the infection until it has progressed to a later stage. 2 Clinical guidelines support treating nearly all individuals with acute or chronic HCV. 3 Globally, hepatitis C imposes a substantial health and economic burden 4 , underscoring the importance of early diagnosis and timely access to treatment. About the Phase 3 M20-350 Study 1 The multicenter, single-arm prospective Phase 3 M20-350 clinical trial was designed to evaluate the safety and efficacy of MAVIRET (glecaprevir/pibrentasvir) eight-week treatment in adults and adolescent participants aged 12 years and older with acute HCV infection. The study enrolled 286 treatment-naïve adult patients with acute HCV infection across 70 locations globally. Patients received oral tablets of MAVIRET once daily for eight weeks and were followed for 12 weeks after the end of treatment. The primary endpoint was the percentage of patients with sustained virological response 12 weeks post-treatment (SVR 12 ) in the intent-to-treat population (ITT). The study met its primary endpoint, with 96.2% of patients in the ITT population achieving SVR 12 (p<0.0001). The key secondary endpoint was also met with 100% of patients in the modified ITT-Virologic Failure population achieving SVR 12 (p<0.0001). The overall safety pro in the M20-350 study was similar to that observed in patients with chronic HCV infection. No serious adverse reactions or adverse reactions leading to treatment discontinuation were observed among patients with acute HCV infection. The most commonly reported adverse reactions were fatigue (3%), asthenia (2%), headache (2%), and diarrhea (2%). No on-treatment virologic failures or post-treatment relapses were observed, and post-treatment reinfection occurred in 0.7% of patients. More information on the study can be found at (NCT04903626). About MAVIRET ® (glecaprevir/pibrentasvir) MAVIRET ® (glecaprevir/pibrentasvir) is an oral, pangenotypic, once-daily, ribavirin-free direct-acting antiviral treatment for chronic hepatitis C virus (HCV) infection. MAVIRET combines glecaprevir, an NS3/4A protease inhibitor, and pibrentasvir, an NS5A inhibitor, and is administered once daily with food. In the European Union, MAVIRET is approved for the treatment of chronic HCV infection in adults and children aged 3 years and older. In adults and adolescents aged 12 years and older, or children weighing at least 45 kg, the recommended dose is three 100 mg/40 mg tablets once daily with food. In children aged 3 years to less than 12 years and weighing 12 kg to less than 45 kg, MAVIRET is available as coated granules in sachets, with dosing based on body weight. MAVIRET is approved for use in patients with chronic HCV infection with compensated liver disease, including those with compensated cirrhosis, and in patients with severe renal impairment, including those on dialysis, according to the approved EU label. Important EU Safety Information: CONTRAINDICATIONS: MAVIRET is contraindicated in patients with severe hepatic impairment (Child-Pugh C). Concomitant use with atazanavir-containing products, atorvastatin, simvastatin, dabigatran etexilate, ethinyl oestradiol-containing products, strong P-gp and CYP3A inducers (e.g., rifampicin, carbamazepine, St. John’s wort [Hypericum perforatum], phenobarbital, phenytoin, and primidone). SPECIAL WARNINGS AND PRECAUTIONS FOR USE: Hepatitis B virus reactivation Cases of hepatitis B virus (HBV) reactivation, some of them fatal, have been reported during or after treatment with direct-acting antiviral agents. HBV screening should be performed in all patients before initiation of treatment. HBV/HCV co-infected patients are at risk of HBV reactivation, and should, therefore, be monitored and managed according to current clinical guidelines. Hepatic impairment MAVIRET is not recommended in patients with moderate hepatic impairment (Child-Pugh B). Patients who failed a prior regimen containing an NS5A and/or an NS3/4A inhibitor MAVIRET is not recommended for the re-treatment of patients with prior exposure to NS3/4A and/or NS5A inhibitors. Use in diabetic patients Diabetics may experience improved glucose control and potential symptomatic hypoglycaemia after initiating HCV direct acting antiviral treatment. Glucose levels should be closely monitored, particularly within the first 3 months of treatment. ADVERSE REACTIONS Most common (≥10%) adverse reactions for MAVIRET were headache and fatigue. This is not a complete summary of all safety information. See MAVIRET full summary of product characteristics (SmPC) at . Globally, prescribing information varies; refer to the individual country product label for complete information. About Enanta Pharmaceuticals, Inc. Enanta is using its robust, chemistry-driven approach and drug discovery capabilities to become a leader in the discovery and development of small molecule drugs for viral infections and immunological diseases. In virology, Enanta’s clinical programs are focused on the development of first-in-disease and best-in-disease treatments for respiratory syncytial virus (RSV). The Company’s immunology pipeline aims to develop treatments for inflammatory diseases by targeting key drivers of the type 2 immune response, with KIT, STAT6 and MRGPRX2 inhibition. Glecaprevir, a protease inhibitor discovered by Enanta, is part of one of the leading treatment regimens for curing hepatitis C virus (HCV) infection and is sold by AbbVie in numerous countries under the tradenames MAVYRET ® (U.S.) and MAVIRET ® (ex-U.S.) (glecaprevir/pibrentasvir). A portion of Enanta’s royalties from HCV products developed under its collaboration with AbbVie contribute ongoing funding to Enanta’s operations. Please visit for more information. Forward Looking Statements Disclaimer This press release contains forward-looking statements, including statements with respect to the prospects for AbbVie sales of Enanta’s licensed products. Statements that are not historical facts are based on management’s current expectations, estimates, forecasts and projections about Enanta’s business and the industry in which it operates and management’s beliefs and assumptions. The statements contained in this release are not guarantees of future performance and involve certain risks, uncertainties and assumptions, which are difficult to predict. Therefore, actual outcomes and results may differ materially from what is expressed in such forward-looking statements. Important factors and risks that may affect actual results include: Enanta’s royalty revenues are dependent upon the continued success of AbbVie’s commercialization of its MAVYRET/MAVIRET regimen; the impact of development, regulatory and marketing efforts of others with respect to competitive treatments for HCV; reimbursement and pricing actions affecting MAVYRET/MAVIRET or any competitive treatment for HCV; Enanta’s need to obtain and maintain patent protection for its product candidates and avoid potential infringement of the intellectual property rights of others; and other risk factors described or referred to in “Risk Factors” in Enanta’s Form 10-K for the fiscal year ended September 30, 2025, and any other periodic reports filed more recently with the Securities and Exchange Commission. Enanta cautions investors not to place undue reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this release, and Enanta undertakes no obligation to update or revise these statements, except as may be required by law. References 1 MAVIRET ® Summary of Product Characteristics. AbbVie; 2026. 2 Hepatitis C. World Health Organization. Available at: . Last accessed: June 2026. 3 European Association for the Study of the Liver, et al. EASL recommendations on treatment of hepatitis C: Final update of the series. J Hepatol. 2020 Nov;73(5):1170-1218. 4 Cacoub P. Comment on Nuño Solinís R, et al. “Value of Treating All Stages of Chronic Hepatitis C: A Comprehensive Review of Clinical and Economic Evidence". Infect Dis Ther . 2017 Jun;6(2):297-301. Contacts Media and Investor Contact Jennifer Viera 617-744-3848 jviera@enanta.com

FAYETTEVILLE, NY, UNITED STATES, January 9, 2026 / EINPresswire.com / -- January is traditionally a peak period for pharmaceutical list price adjustments. The AnalySource team analyzed Wholesale Acquisition Cost (WAC) package pricing changes for all single-source prescription products with effective dates surrounding the new year, spanning December 1, 2025 through February 28, 2026. Overall, the analysis shows that most price changes were modest, though a limited number of notable outliers were observed. The analysis encompassed 1,902 National Drug Codes (NDCs) representing all identified single-source products with WAC package pricing changes during the analysis period. Only a small subset exhibited material pricing movement, with 11 drugs, some with various formulations, reporting WAC package price decreases and 31 products recording WAC package price increases of 10% or greater. These findings underscore that large price movements remain the exception rather than the norm, even during peak annual pricing cycles. Several significant outliers stood out in the data. Sandoz’s CIMERLI reported an 85.29% decrease in WAC package price, representing the largest reduction observed during the period. The largest WAC package price increase in the dataset was reported by PAI Holdings for TRIHEXYPHENIDYL (+480%). In addition, the most extreme WAC package price increases were highly concentrated within a small number of manufacturers, with Hospira/Pfizer accounting for the majority of increases exceeding 300%, including Verapamil HCl (+377%), Lorazepam (+346%), Naloxone HCl (+334%), and Hydromorphone HCl (+318%). These products are commonly used in hospital and acute care settings, where pricing dynamics may differ from those of outpatient or retail-dispensed therapies. Other notable movements included Sprout Pharmaceuticals, which reported a 110.64% increase for ADDYI, a branded product indicated for sexual function disorders. Novo Nordisk implemented substantial price decreases across multiple insulin products, including Fiasp and Tresiba presentations, reflecting a coordinated portfolio-level pricing adjustment rather than isolated product changes. Several manufacturers exhibited mixed pricing strategies within their portfolios. Boehringer Ingelheim reported modest price increases for products such as Ofev, Pradaxa, and Gilotrif while simultaneously implementing price decreases of approximately 44% for several other products. Pfizer reported both significant price increases across select hospital and specialty products and a price decrease for Xeljanz, a therapy used in inflammatory conditions. Outside of these exceptions, most manufacturers reported modest WAC package price increases in the range of 2% to 6%, consistent with historical annual pricing patterns. Across therapeutic areas, these adjustments align with routine pricing activity that may reflect product lifecycle stage, competitive dynamics, manufacturing considerations, and regulatory developments. While additional list price adjustments are expected later in the pricing cycle, early indications suggest that the majority of products will continue to reflect modest pricing changes, with large increases and decreases remaining relatively limited. The AnalySource team will continue to monitor these developments closely and will provide further updates as additional information becomes available. Daniel Miccio DMD America, Inc. +1 315-400-2289 email us here Visit us on social media: LinkedIn Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.