FDA approves Merck & Co’s Zepatier for hepatitis C

pharmafield logo - pharma news

The US Food and Drug Administration has given the green light to Merck & Co’s hepatitis C combination Zepatier for patients with genotype 1 and 4 infections.

The approval of Zepatier (elbasvir/grazoprevir) is based on data showing that the overall sustained virologic response (SVR) ranged from 94-97% in genotype 1-infected subjects and 97-100% for those with genotype 4. Merck says that the price will be $54,600 for a 12-week treatment regimen.

Zepatier joins a market currently dominated by Gilead’s Sovaldi (sofosbuvir) and Harvoni (sofosbuvir/ledipasvir) and featuring AbbVie’s Viekira Pak (ombitasvir/paritaprevir/ritonavir) and Bristol-Myers Squibb’s Daklinza (daclatasvir). Some observers believe the increased competition will lead to insurers and other payers getting bigger discounts on these high-priced treatments.