The regulator also backed a new drug from Dainippon
Sumitomo Pharma called Latuda, for the treatment of schizophrenia,
and Bemfola, a new biosimilar medicine for the treatment of
infertility.
But the European Medicine Agency (EMA) decided against recommending
Teva's new multiple sclerosis pill Nerventra, or laquinimod, and
recommended rejecting an application from the Swiss drugmaker
Novartis to market its heart failure drug serelaxin.
EMA's committee also issued negative opinions for two so-called
orphan medicines — Masiviera from France AB Science, intended for
the treatment of certain types of advanced pancreatic cancer — and
Translarna, from PTC Therapeutics, designed to treat Duchenne
muscular dystrophy.
Recommendations for marketing approval by the European Medicine
Agency's Committee for Medicinal Products for Human Use (CHMP) are
normally endorsed by the European Commission within a couple of
months.
(Reporting by Kate Kelland; editing by
Tom Pfeiffer)
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