10:26 AM
Nov 30, 2018
 |  BC Week In Review  |  Clinical News  |  Regulatory

CHMP backs first all-oral sleeping sickness treatment, extensions for Blincyto, Opdivo-Yervoy combo

EMA's CHMP recommended a basket of approvals and label extensions on Nov. 16, including the first all-oral treatment for African trypanosomiasis (sleeping sickness). The agency issued no negative opinions in its monthly roundup.

The agency backed fexinidazole, an antiprotozoal nitroimidazole, from Sanofi (Euronext:SAN; NYSE:SNY) as the first oral therapy sufficient to treat sleeping sickness caused by Trypanosoma brucei gambiense. In contrast with other therapies, which require hospitalization, fexinidazole is effective for both early and late phases of disease -- before and after the parasite crosses the blood-brain barrier.

CHMP backed the drug under the Article 58 procedure, which allows the agency to assess...

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