Astellas’ Fungal Infection Treatment Granted FDA QIDP Status

Astellas’ fungal infection drug isavuconazole has been granted a special status by the FDA that would tack on an extra five years of market exclusivity if the product is approved.

Proposed to treat invasive mucormycosis, the Astellas antibiotic also enjoys priority review status under the agency’s qualified infectious disease product (QIDP) program, introduced last year to incentive development of new drugs targeting pathogens that most endanger the public. The incentives were granted under the GAIN Act as part of the FDA Safety and Innovation Act.

If the antibiotic is approved, isavuconazole would enjoy 12 years of market exclusivity as the product last year also received an orphan drug designation from the FDA for the treatment of zygomycosis, the drugmaker said Thursday. Isavuconazole was also granted fast-track status and has received orphan drug designation for the treatment of invasive aspergillosis, Astellas added.

Isavuconazole, currently in Phase III, is a once-daily intravenous and oral broad-spectrum antifungal for the potential treatment of severe invasive and life-threatening fungal infections. The drug is being co-developed by the Japan’s Astellas and Swiss-owned Basilea Pharmaceutica. — Johnathan Rickman

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