Gilead's Pan-Genotypic HCV Drug Epclusa Gains EU Approval

Positive news flowed in at Gilead Sciences Inc. (NASDAQ:GILD) with the European Commission approving the marketing authorization application for Epclusa (Sovaldi 400 mg/velpatasvir 100 mg), the first pan-genotypic, single-tablet regimen for the treatment of adults with genotype 1-6 chronic hepatitis C virus (HCV) infection. The company’s shares inched up 1.3% on the news.

The combination for 12 weeks is approved for the treatment of patients without cirrhosis or with compensated cirrhosis (Child-Pugh A) and in combination with ribavirin (RBV) for patients with decompensated cirrhosis (Child-Pugh B or C). Epclusa is also the first single-tablet regimen approved for the treatment of patients with HCV genotype 2 and 3, without the need for RBV. Physicians will however have the flexibility to consider the addition of RBV for genotype 3 infected patients with compensated cirrhosis.

EU approval was largely expected as the Committee for Medicinal Products for Human Use had issued a favorable opinion this May, which was adopted following an accelerated review procedure.

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We note that Epclusa is Gilead’s third sofosbuvir-based treatment to gain approval in the EU for the treatment of chronic HCV infection and is expected to complement Gilead’s current HCV portfolio consisting of Sovaldi and Harvoni.

We remind investors that Epclusa gained FDA approval for the treatment of adults with genotype 1-6 chronic HCV late last month. We are encouraged by the company’s efforts in expanding its HCV franchise. 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 #2 (Buy) stock. A couple of other favorable stocks in the health care sector are Innoviva, Inc. (NASDAQ:INVA) and Fibrocell Science, Inc. (NASDAQ:FCSC) , each sporting a Zacks Rank #1 (Strong Buy).