Following the strong initial sales of its potential blockbuster hepatitis C virus (HCV) treatment, Sovaldi (nucleotide analog polymerase inhibitor), Gilead Sciences (GILD) is looking to bring another HCV treatment – a fixed-dose combination Sovaldi and ledipasvir (NS5A inhibitor) into the market.
With a view to achieve the above objective, Gilead submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval to market the cocktail therapy for treating adults with chronic hepatitis C virus (HCV) genotype 1 infection in Feb 2014. 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 substantially 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. suffer from the genotype 1 version.
The FDA announced that it will review the application on a priority basis. The FDA reviews applications for priority review designated drugs within eight months of submission as against the usual 12 months. Consequently, a decision from the FDA is expected by Oct 10, 2014 (target date). We note that the U.S. regulatory authority generally reviews those drugs, which offer major advances in treating diseases over existing therapies, on a priority basis.
The fixed dose regimen is also under review in the EU for the same indication. The European Medicines Agency (EMA) validated the biopharmaceutical company's marketing application for the candidate last month and at the same time accepted Gilead's request for an accelerated assessment of the application. Acceptance of the request has reduced the EMA's review period of the application by two months.
We note that AbbVie (ABBV) is also aiming to bring an all-oral, interferon-free therapy into the market for treating genotype 1 HCV.
Gilead carries a Zacks Rank # 3 (Hold). Better-ranked stocks in the biopharma space include Alkermes (ALKS) and Alexion Pharmaceuticals (ALXN). Both stocks carry a Zacks Rank #1 (Strong Buy).
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