Good news flowed in at Gilead Sciences (GILD) with the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommending the approval of Gilead’s Harvoni for treating adults affected with chronic hepatitis C infection. Harvoni is the proposed brand name in the EU for the once daily fixed-dose combination of ledipasvir (a NS5A inhibitor: 90 mg) and Sovaldi (sofosbuvir: 400 mg).
The CHMP rendered its opinion after an accelerated review procedure. The procedure is adopted for candidates that are expected to be of primary public interest. The CHMP’s opinion will now be reviewed by the European Commission (EC) with a final decision expected in the next few months. We expect the EC to approve the cocktail therapy.
The CHMP’s favorable opinion was based on 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 with compensated liver disease. Apart from data from the above mentioned studies, CHMP also considered data from SOLAR-1 (decompensated cirrhotic and pre- and post-transplant patients), ELECTRON-2 (genotype 3 patients) and phase II studies on genotype 4 HCV patients before rendering the favorable opinion.
Approval of the combination oral therapy would boost Gilead’s top line further as the HCV market in Europe offers significant commercial potential with the dreaded infection affecting approximately nine million people there, according to Gilead. Gilead also stated that the majority of the HCV affected population in Europe suffer from the genotype 1 version. The CHMP opinion comes close on the heels of Gilead seeking Japanese approval for the cocktail therapy (read more: Gilead (GILD) Seeks Japanese Approval for HCV Combo Drug).
The fixed dose combination is also under review in the U.S. with a decision expected next month. Apart from Gilead, AbbVie (ABBV) is also looking to bring its HCV combination therapy into the market.
Gilead carries a Zacks Rank #1 (Strong Buy). Medivation (MDVN) and Endo International (ENDP) are equally well-ranked stocks in the health care space.
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