Basilea Pharmaceutica Ltd. reports today that it submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) seeking approval of isavuconazole for the treatment of invasive aspergillosis and mucormycosis (zygomycosis). Basilea's co-development partner Astellas Pharma Inc. also recently submitted a New Drug Application (NDA) for isavuconazole to the U.S. Food and Drug Administration (FDA).

Ronald Scott, Basilea's Chief Executive Officer, stated: "New antifungal therapies are urgently needed due to the increasing number of immunocompromised patients who are at risk for developing invasive fungal infections such as cancer patients undergoing chemotherapy. The isavuconazole regulatory submission in the EU is a major achievement for Basilea and complements the U.S. submission by our partner Astellas."

Isavuconazole (drug substance: isavuconazonium sulfate) is an investigational once-daily intravenous and oral broad-spectrum antifungal for the potential treatment of life-threatening invasive fungal infections which predominantly occur in immunocompromised patients. In the European Union (EU), isavuconazole was recently granted orphan drug status for the treatment of invasive aspergillosis and mucormycosis, providing ten years of market exclusivity independent of any existing patent protection should the product be approved in the EU. In the U.S., isavuconazole was granted FDA fast-track status and designated a Qualified Infectious Disease Product (QIDP) for invasive aspergillosis, mucormycosis and candidiasis under the U.S. GAIN Act. QIDP status provides priority review and, if the product is approved, a five-year extension of market exclusivity in the United States. In addition, isavuconazole received U.S. orphan drug designations for invasive aspergillosis and mucormycosis.

For more details, go to: http://www.basilea.com/News-and-Media/Basilea-submits-isavuconazole-European-Marketing-Authorization-Application-for-the-treatment-of-invasive-mold-infections/4829da89-e609-b167-721d-8e68389b5ba6