EMA OKs Seven New Drugs But Delivers Another Blow To Emmaus
Seven new drugs have this week moved closer to gaining EU approval following positive recommendations from the European Medicines Agency, but Emmaus’ glutamine product has fared less well and the company is considering another route for getting the drug to sickle cell disease patients in Europe
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The European Medicines Agency this year is known to have granted ten requests for accelerated assessment of planned EU marketing authorization applications. Nine such requests are known to have been rejected. As 2019 draws to a close, the outcomes of five requests are still unknown.
Janssen’s two investigational Ebola vaccines are among four new products recently granted fast-track review by the European Medicines Agency. GlaxoSmithKline and Viiv Healthcare are not disclosing the outcomes of accelerated assessment requests they have made.
It’s decision time again at the European Medicines Agency and Roche’s Polivy is one of the new drug applications that is up for a potential marketing recommendation.