Gilead Sciences Inc. (NASDAQ:GILD) announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has rendered a positive opinion in favor of the approval of the company’s marketing authorization application for Epclusa.
Gilead is looking to get Epclusa approved for the treatment of adults with all genotypes (1-6) of chronic hepatitis C virus (HCV) infection. Epclusa is an experimental pan-genotypic, once-daily combination of Gilead’s HCV drug Sovaldi (400 mg) and velpatasvir (a pan-genotypic NS5A inhibitor; 100 mg).
The favorable opinion of the CHMP, which was adopted following an accelerated review procedure, will now be reviewed by the European Commission. With the CHMP issuing a positive opinion, we believe that chances of Epclusa gaining EU approval are pretty high.
We remind investors that Epclusa is currently under priority review in the U.S. for the same indication. A response from the FDA is expected by Jun 28.
Epclusa could become the first pan-genotypic, all-oral, single-tablet regimen to gain approval and will complement the company’s current HCV portfolio consisting of Sovaldi and Harvoni. Competition and pricing pressure have already intensified in the HCV market with the entry of a new competitor – Merck & Co. Inc.’s (NYSE:MRK) Zepatier.
Meanwhile, Gilead is also evaluating a once-daily fixed-dose combination of Sovaldi/velpatasvir plus GS-9857 (an experimental NS3 protease inhibitor) in phase III studies, for the treatment of chronic genotype 1-6 HCV.
Gilead is a Zacks Rank #3 (Hold) stock. A couple of better-ranked stocks in the health care sector are ANI Pharmaceuticals, Inc. (NASDAQ:ANIP) and Retrophin, Inc. (NASDAQ:RTRX) – each sporting a Zacks Rank #1 (Strong Buy).
MERCK & CO INC (MRK): Free Stock Analysis Report
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RETROPHIN INC (RTRX): Free Stock Analysis Report
ANI PHARMACEUT (ANIP): Free Stock Analysis Report
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