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Reuters Health Information (2014-03-21): EMA committee backs J&J hepatitis C pill plus new drugs from Lilly, Takeda

Regulatory

EMA committee backs J&J hepatitis C pill plus new drugs from Lilly, Takeda

Last Updated: 2014-03-21 11:48:36 -0400 (Reuters Health)

LONDON (Reuters) - A committee of the European Medicines Agency (EMA) has recommended approval of a new oral treatment for hepatitis C from Johnson & Johnson, underscoring the rapid development of oral treatment options for the disease.

The green light from the EMA's Committee for Medicinal Products for Human Use (CHMP) for J&J's Olysio (simeprevir) follows U.S. approval for the treatment in November.

The drug, which was developed in collaboration with Sweden's Medivir, is one of several that is vying for a share of a major new market in treatments for hepatitis C. The new wave of pills cut the need for debilitating interferon injections.

Gilead's hepatitis C pill Sovaldi (sofosbuvir) is already available in the United States and has been recommended for approval in Europe, while other companies including AbbVie are also working on promising oral treatments.

The EMA Committee also said on Friday it had backed new drugs from Eli Lilly, Takeda and Endocyte.

Eli Lilly and its partner Boehringer Ingelheim received a recommendation for their diabetes medicine Jardiance (empagliflozin), which failed to win U.S. approval earlier this month because of manufacturing issues.

Japan's Takeda, meanwhile, secured a recommendation for Entyvio (vedolizumab) as a treatment for moderate to severe ulcerative colitis and Crohn's disease.

The Committee also gave its backing to Vynfinit (vintafolide), together with companion diagnostics, from Endocyte and Merck & Co, for ovarian cancer patients, plus another J&J drug for multicentric Castleman's disease, a rare blood condition.

Recommendations for marketing approval by the EMA's CHMP are normally endorsed by the European Commission within a couple of months.

 
 
 
 
                 
 
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