The newly FDA approved medication Zepatier is a once-a-day pill taken for 12 or 16 weeks to treat hepatitis C genotype-1 and genotype-4.
The US Food and Drug Administration last week approved a new drug by pharmaceutical giant Merck to treat chronic hepatitis C in patients with the most and least common two genotypes.
The drug will cost $54,600 for a 12-week course, according to Merck.
In two separate releases Thursday, the FDA and Merck announced approval of the drug that will be marketed in the US as Zepatier. Merck submitted its drug application in June of last year and was granted breakthrough therapy designation by the FDA, which served to accelerate the review process.
“Today’s approval provides another oral treatment option for patients with genotypes 1 and 4 HCV infections without requiring use of interferon,” Edward Cox, MD, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, states in the FDA release.
Chronic infection of the hepatitis C virus inflames the liver and can lead to severe liver damage or liver failure. Many people with the disease have no symptoms for years until the damage becomes apparent, states the FDA release.
The president of Merck Research Laboratories, Roger Perlmutter, said in the company release that Zepatier’s approval is a testament to his company’s commitment to improving therapy for patients who are infected with hepatitis C. The company expects to begin shipping drug to wholesalers within seven business days.
Read Full Article: Zepatier Offers New Option for Patients with Chronic Hepatitis C