Merck & Co files grazoprevir/ elbasvir NDA in USA

29 May 2015

US pharma giant Merck (NYSE:MRK) has submitted a New Drug Application to the US Food and Drug Administration for grazoprevir/elbasvir (100mg/50mg), an investigational once-daily, single tablet combination therapy for the treatment of adult patients with chronic hepatitis C genotypes (GT) 1, 4 or 6 infection.

Within 60 days of submission, the FDA will determine whether it will accept for review Merck's application as filed. The company plans to submit additional license applications in the European Union and other markets by the end of 2015.

“Merck's submission is based on evidence from our wide-ranging clinical program assessing the efficacy and tolerability profile of grazoprevir/elbasvir in populations with chronic hepatitis C,” said Roy Baynes, senior vice president of clinical development, Merck Research Laboratories. “This submission to the US FDA is an important milestone as we seek to provide patients with a new treatment option for this serious infection,” Dr Baynes added.

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