Gilead Sciences, Inc. GILD announced that its Marketing Authorisation Application (MAA) for a once-daily, fixed-dose combination of its blockbuster hepatitis C virus (HCV) infection drug, Sovaldi with velpatasvir (an investigational pangenotypic NS5A inhibitor), has been fully validated and is now under assessment by the European Medicines Agency (EMA). The EMA has granted accelerated assessment to the MAA.
Gilead is looking to get the combination approved for the treatment of genotype 1-6 chronic HCV infection, including patients with compensated and decompensated cirrhosis. If approved, the company expects to make the drug available in the EU in 2016. Gilead has also submitted a regulatory application for Sovaldi/velpatasvir to the FDA. The fixed-dose combination enjoys Breakthrough Therapy status in the U.S. Note that Breakthrough Therapy status is granted to candidates that have the potential to offer major advances in treatment over existing options.
However, Gilead’s HCV drugs have been witnessing a slowdown in sales. In the third quarter of 2015, Sovaldi sales plunged 47.6% from a year ago owing to the availability of newer HCV therapies including Harvoni and AbbVie Inc.’s ABBV Viekira Pak, among others. Harvoni witnessed a sequential fall in revenues due to a gradual decrease in demand from the retail market during the quarter. In this scenario, a label expansion for Harvoni will be a major win for the company. It should boost the drug’s sales.
Meanwhile, competition in the HCV market is intensifying as several companies like Merck & Co. Inc. MRK are looking to bring their HCV treatments to the market.
Gilead currently carries a Zacks Rank #2 (Buy). Baxalta Incorporated BXLT is another well-ranked stock in the health care sector, sporting a Zacks Rank #1 (Strong Buy).
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