Grazoprevir/elbasvir combination filed at FDA to treat hepatitis C (GT) 1, 4 or 6 infection-Merck Inc.
Merck has announced that the company has submitted a New Drug Application to the FDA 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.
The FDA has previously granted Breakthrough Therapy designation status for grazoprevir/elbasvir for the treatment of patients infected with chronic HCV GT1 with end stage renal disease on hemodialysis, and for patients infected with chronic HCV GT4. Breakthrough Therapy designation is intended to expedite the development and review of a candidate that is planned for use, alone or in combination, to treat a serious or life-threatening disease or condition when preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints.
The New Drug Application for grazoprevir/elbasvir (100mg/50mg) is based in part upon data from the pivotal C-EDGE clinical trials program, as well as the C-SURFER and C-SALVAGE trials, evaluating grazoprevir/elbasvir (100mg/50mg), with or without ribavirin, in patients with chronic hepatitis C infection. Data from these trials were presented at The International Liver Congress 2015 in April 2015.
Comment: The combination will compete with market dominant Harvoni and Sovaldi from Gilead as well as Viekira Pak from AbbVie. The Merck combination has positive evidence for a twelve week course of treatment but not for six or eight week treatment courses now in development. An advantage for Merck is that grazoprevir + elbasvir is a single pill and its competitors require multiple tablets.
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