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Gilead Seeks U.S. Approval

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In a bid to strengthen its product portfolio further, Gilead Sciences, Inc. (GILD - Free Report) has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval to market the fixed-dose combination of ledipasvir ( a NS5A inhibitor: 90 mg) and sofosbuvir: 400 mg for treating adults with chronic hepatitis C virus (HCV) genotype 1 infection. Gilead filed the marketing application on the basis of encouraging data from three phase III studies (ION-1, ION-2 and ION-3).

The studies evaluated the combination with or without ribavirin in almost 2000 genotype 1 chronic hepatitis C patients. The approval of the combination would not only reduce the treatment duration of chronic hepatitis C genotype 1 infection to as low as eight weeks but also eliminate the need for interferon injections or ribavirin which have significant side effects. Gilead stated that 75% of the HCV affected population in the U.S. suffers from the genotype 1 version.

We note that the combination has been granted breakthrough therapy designation by FDA. The designation, which was enacted as part of the 2012 Food and Drug Administration Safety and Innovation Act, should help fasten the development and review process for the candidate.

Gilead also intends to get the candidate approved in other territories across the globe. Gilead has already filed an application to the European Medicines Agency (EMA) for accelerated assessment of the combination. Acceptance of the request could reduce the EMA’s review period of the application by two months.

We note that one of the components of the combination – sofosbuvir- is already approved in the U.S. (Dec 2013) and the EU (Jan 2014) under the trade name Sovaldi. Sovaldi is off to a strong start and recorded U.S. sales of $136.4 million in the fourth quarter of 2013. Sovaldi, with its high cure rates, a short treatment period and reduction/elimination of the need for interferon injections, has the potential to change the treatment paradigm in the HCV space.

Approval of the all oral ledipasvir/ sofosbuvir combination would further strengthen Gilead’s product portfolio. We note that AbbVie (ABBV - Free Report) is also aiming to bring an all-oral, interferon-free therapy into the market for treating genotype 1 HCV.

Gilead, a biopharmaceutical company, carries a Zacks Rank #2 (Buy). Better-ranked biopharma stocks include Actelion Ltd. and Alexion Pharmaceuticals, Inc. (ALXN - Free Report) . Both companies carry a Zacks Rank #1 (Strong Buy).

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