Astellas' isavuconazole NDA accepted by US FDA

The US Food and Drug Administration has accepted a New Drug Application filing by Japanese drug major Astellas Pharma (TYO: 4503) for its fungal infection therapy isavuconazole.

The drug treats invasive aspergillosis and invasive mucormycosis, life-threatening fungal infections that largely occur in immunocompromized patients.

The FDA has designated March 8, 2015, for the completion of the review. It has already designated isavuconazole as a Qualified Infectious Disease Product for both indications, which provides priority review and a five-year extension of marketing exclusivity in the USA. The treatment was also granted Orphan Drug status for invasive aspergillosis and invasive mucormycosis, which, if approved, will result in seven years of market exclusivity in addition to that provided by the GAIN Act.