Epclusa gains a pediatric HCV approval from the FDA
… With a new FDA supplemental approval, pediatric HCV patients and their physicians have easier access to Epclusa (sofosbuvir and velpatasvir) …

Gilead Sciences’ Epclusa Scores Pediatric Hep C Win

Supplemental application to treat hepatitis C approved by FDA

John G. Baresky

Epclusa (sofosbuvir and velpatasvir), in combination with ribavirin, has been issued a supplemental approval to be used in children ages 6 years and older or weighing at least 37 pounds (17 kilograms) diagnosed with any of the six Hepatitis C virus (HCV) genotypes — or strains — without cirrhosis (liver disease) or with mild cirrhosis. Up to now, Epclusa was approved to treat HCV in adults only. Gilead Sciences was granted a Priority Review of Epclusa by the FDA for this application. Pediatric HCV patients and their parents and healthcare professionals will immediately benefit from this new supplement to Sepclusa’s original indication.

Epclusa is a tablet administered orally. Sofosbuvir is a nucleotide analog inhibitor of hepatitis C virus NS5B polymerase which is the primary enzyme mediating HCV RNA replication. Velpatasvir is an NS5A inhibitor (also produced by Gilead) that is used in conjunction with Sofosbuvir. Epclusa was launched in 2016.

HCV is a viral disease characterized by a liver infection caused by the hepatitis C virus (HCV). Hepatitis C is a blood-borne virus and for some people, hepatitis C is a short-term illness but for 70%–85% of people who become infected with the hepatitis C virus, it becomes a long-term, chronic infection. About 3 million people are diagnosed annually with HCV.

Epclusa’s new indication is a significant benefit for pediatric HCV patients. Not only is it an effective agent but its new indication enables physicians to prescribe the product more easily based on its FDA approval and be within the guidelines of pharmacy or medical insurance plans and formulary rules.

In pediatric cases of HCV, children are born to HCV-positive mothers. There is no vaccine available to prevent HCV and it may result in long-term health issues and some cases it is fatal. Before 1992, HCV was sometimes spread through blood transfusions and organ transplants. Routine testing of the U.S. blood supply for HCV helped resolve this issue, it is now uncommon for infection to occur this way.

Based in Foster City, California (south of San Francisco), Gilead Sciences (NASDAQ: GILD) was founded in 1987 and generates over $22 billion in sales annually. As a global leader in biopharmaceuticals, it employs about 11,000 workers.

Gilead is no slouch when it comes to developing and commercializing products used to help patients and clinicians overcome the odds. It currently markets products used in the treatment of cardiovascular, cell therapy, HIV/AIDS, inflammation, liver disease, oncology, respiratory and other challenging healthcare issues. The additional FDA endorsement of Epclusa for pediatric HCV patients is a great example of maximizing the use of existing advanced therapies to care for more patients.

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