Merck ($MRK), working to scratch out a place in the market for next-generation hepatitis C cures, filed its new combination treatment for FDA approval in hopes of taking third place in a fast-crowding field.
The U.S. pharma giant submitted a one-tablet combination of grazoprevir and elbasvir, two agents designed to halt hep C's ability to replicate itself and survive in the body. Merck is angling for approval in patients with genotypes 1, 4 and 6 of the virus, and the FDA has granted the combo its breakthrough-therapy designation as a treatment for genotype 1 sufferers with end-stage renal disease on hemodialysis and for those with genotype 4, promising a speedy review on at least those indications.
Now the agency has 60 days to decide whether to accept Merck's filing, after which point it will spend up to 10 months reviewing grazoprevir and elbasvir before making a final decision. Analysts have said that, with a little luck, Merck might be able to launch the drug by year's end.
The combo therapy is Merck's gambit to catch up with Gilead Sciences ($GILD) and AbbVie ($ABBV) in the rapidly changing hep C market. Those two companies are raking in billions with their recently approved combos, Harvoni and Viekira Pak, all while developing follow-on cocktails designed to rid patients of the virus in less and less time. Behind them is a cadre of drugmakers including Bristol-Myers Squibb ($BMY) and Johnson & Johnson ($JNJ), each at work on proprietary mix-and-match therapies.
Merck's combo has thus far proven itself as a 12-week cure, putting it on par with the two treatments already on the market but not the 6- or even four-week regimens in development.
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