Gilead Gets Positive EU Opinion On Proprietary HCV Combo Pill Harvoni

Europe’s top scientific advisory panel has cleared for approval Gilead’s new hepatitis C antiviral combination of sofosbuvir plus ledipasvir, as well as Almirall’s new inhaled combo of aclidinium and formoterol and AstraZeneca’s new constipation therapy naloxegol.

Among the bumper crop of approval recommendations from the EU’s Committee for Medicinal Products for Human Use (CHMP) announced Sept. 26 were Gilead Sciences Inc.’s hepatitis C combination Harvoni (sofosbuvir plus ledipasvir), AstraZeneca PLC’s opioid-induced constipation therapy Moventig (naloxegol), and Almirall SA’s twice-daily COPD therapy Duaklir Genuir (aclidinium plus formoterol fumarate dehydrate).

In total, 15 new products, containing seven new molecular entities, were recommended for marketing approval in Europe following the CHMP’s meeting on Sept. 22 through to Sept. 25, including filings from Eli Lilly & Co

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