{"id":502929,"date":"2021-06-10T17:03:57","date_gmt":"2021-06-10T21:03:57","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/u-s-food-and-drug-administration-approves-new-formulation-of-epclusa-expanding-pediatric-indication-to-treat-children-ages-3-and-older-with-chronic-hepatitis-c\/"},"modified":"2021-06-10T17:03:57","modified_gmt":"2021-06-10T21:03:57","slug":"u-s-food-and-drug-administration-approves-new-formulation-of-epclusa-expanding-pediatric-indication-to-treat-children-ages-3-and-older-with-chronic-hepatitis-c","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/u-s-food-and-drug-administration-approves-new-formulation-of-epclusa-expanding-pediatric-indication-to-treat-children-ages-3-and-older-with-chronic-hepatitis-c\/","title":{"rendered":"U.S. Food and Drug Administration Approves New Formulation of Epclusa\u00ae, Expanding Pediatric Indication to Treat Children Ages 3 and Older With Chronic Hepatitis C"},"content":{"rendered":"

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U.S. Food and Drug Administration Approves New Formulation of Epclusa\u00ae<\/sup>, Expanding Pediatric Indication to Treat Children Ages 3 and Older With Chronic Hepatitis C<\/b><\/p>\n

\n\u2013 New Oral Pellet Formulation Enables Treatment in Early Childhood with Pangenotypic, Panfibrotic Regimen <\/i><\/b>\u2013\n<\/p>\n

FOSTER CITY, Calif.–(BUSINESS WIRE<\/a>)–
\nGilead Sciences, Inc. (Nasdaq: GILD) announced today that the U.S. Food and Drug Administration (FDA) has approved an expansion of the pediatric indication of Epclusa\u00ae<\/sup> (sofosbuvir\/velpatasvir) for the treatment of chronic hepatitis C virus (HCV) to now include children as young as 3 years of age, regardless of HCV genotype or liver disease severity. The FDA approved a New Drug Application (NDA) for two strengths of an oral pellet formulation of Epclusa (sofosbuvir 200 mg\/velpatasvir 50 mg and sofosbuvir 150 mg\/velpatasvir 37.5 mg) developed for use by younger children who cannot swallow tablets. The recommended dosage of Epclusa in children ages 3 years and older is based on weight.\n<\/p>\n

\nTreatment with Epclusa for 12 weeks was approved in patients without cirrhosis or with compensated cirrhosis (Child-Pugh A), and in combination with ribavirin (RBV) for patients with decompensated cirrhosis (Child-Pugh B or C). Sofosbuvir\/velpatasvir is the only protease inhibitor-free, pangenotypic HCV regimen approved for patients as young as 3 years of age.\n<\/p>\n

\nIn the United States, as of 2018 there were approximately 35,300 to 60,500 children living with HCV and incidence has been on the rise. Mother-to-child transmission, the most common cause of HCV infection in children, increased 161% from 2009 to 2017, with intravenous drug use representing the primary driver of HCV infection among women of childbearing age.\n<\/p>\n

\n\u201cGilead remains steadfast in our commitment to supporting HCV elimination. Today\u2019s decision by the FDA represents important progress toward that goal by expanding more cure options for children living with HCV,\u201d said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences. \u201cThis approval adds to the robust clinical evidence supporting the safety and efficacy of Epclusa across a broad set of patients, including those with end-stage renal disease and all stages of fibrosis.\u201d\n<\/p>\n

\nThe approval of Epclusa for children as young as 3 years of age is based on data from a Phase 2, open-label clinical trial that enrolled 41 children 3 years to less than 6 years of age to be treated with Epclusa for 12 weeks. At 12 weeks after treatment completion, Epclusa achieved a sustained virologic response (SVR12) or cure rate of 83% (34\/41) among all patients, 88% (28\/32) in children with HCV genotype 1, 50% (3\/6) in children with HCV genotype 2, and 100% in children with HCV genotype 3 (2\/2) and HCV genotype 4 (1\/1). Of the seven patients who did not achieve cure, all discontinued treatment within one to 20 days of starting treatment.\n<\/p>\n

\nThe safety profile of Epclusa in children 3 to less than 6 years of age treated was generally consistent with that observed in clinical trials in adults. Vomiting and product use issue (spitting up the drug) were reported in 15% and 10% of subjects, respectively; these adverse reactions were mild (Grade 1 or 2) and led to treatment discontinuation in 5 (12%) subjects.\n<\/p>\n

\nPlease see below for the U.S. Indication and Important Safety Information, including BOXED WARNING, for Epclusa.\n<\/p>\n

\n\u201cTreating pediatric HCV remains an important public health priority. The Phase 2 clinical trial results previously showed that this medication was effective in treating many HCV-infected patients, regardless of genotype,\u201d said Karen Murray, MD, Chair of Cleveland Clinic Children\u2019s and lead investigator of the pediatric study. \u201cNow, the expanded approval and oral pellet formulation offer new treatment strategies in younger patients with HCV.\u201d\n<\/p>\n

U.S. IMPORTANT SAFETY INFORMATION AND INDICATION FOR THE USE OF EPCLUSA <\/b><\/p>\n

BOXED WARNING: RISK OF HEPATITIS B VIRUS REACTIVATION IN HCV\/HBV COINFECTED PATIENTS<\/b><\/p>\n

Test all patients for evidence of current or prior hepatitis B virus (HBV) infection before initiating treatment with EPCLUSA. HBV reactivation has been reported in HCV\/HBV coinfected patients who were undergoing or had completed treatment with HCV direct acting antivirals (DAAs) and were not receiving HBV antiviral therapy. Some cases have resulted in fulminant hepatitis, hepatic failure, and death. Cases have been reported in patients who are HBsAg positive, in patients with serologic evidence of resolved HBV, and also in patients receiving certain immunosuppressant or chemotherapeutic agents; the risk of HBV reactivation associated with treatment with HCV DAAs may be increased in patients taking these other agents. Monitor HCV\/HBV coinfected patients for hepatitis flare or HBV reactivation during HCV treatment and post-treatment follow-up. Initiate appropriate patient management for HBV infection as clinically indicated.<\/b><\/p>\n

Contraindications<\/b><\/p>\n