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-threatening condition and is common among immunocompromised patients. The efficacy and safety of the newly proposed therapy were observed against the presently available standard treatment with voriconazole.
However, the panel did not cast a complete vote in favor of isavuconazonium’s use for treating invasive mucormycosis. Members argued that only 37 patients were studied in the testing phases of the drug, which does not prove the drug efficacy substantially. Committee members who cast their votes in favor urged Astellas to conduct a phase IV study to further determine the drug while treating patients with this infection.
Isavuconazonium is aimed to act as a prodrug of a triazole antifungal, called isavuconazole. The prodrug would be available in the form of an oral capsule, as well as in powder formation for intravenous administration.
Although the FDA is not bound to accept the recommendations of the Advisory committee, which acts according to its own independent expertise, the authorizing body will consider the input from the panel. As per the timelines, it is expected that the NDA review will be over by March 8, 2015.