Astellas’s Isavuconazonium was positively recommended to the FDA

January 24, 2015 4:40 PM

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Astellas said that the Anti-infective Drugs Advisory Committee of the U.S. Food and Drug Administration has cast a unanimous vote in favor of its proposed therapy to treat invasive aspergillosis. The therapy also received a majority vote in support of its usage in the treatment of invasive mucormycosis. While, in the first case, the vote count was 11-0, in the second case, the vote was in the ratio of 8-2. The drug received hesitant approval in case of invasive mucormycosis because of the limited data available.

The decision of the committee was announced on the January 22 meeting. The committee agreed that the antifungal prodrug, isavuconazonium, has provided substantial evidence regarding its safety, as well as efficacy in the treatment of invasive aspergillosis. The disease condition is a life-threatenin...

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