Astellas Seeks FDA Nod for Fungal Infection Treatment - Analyst Blog

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Astellas Pharma, Inc. ( ALPMY ) has filed a new drug application (NDA) with the FDA for isavuconazole for the treatment of invasive aspergillosis and mucormycosis (also known as zygomycosis).

Astellas and partner Basilea Pharmaceutica Ltd. are jointly developing isavuconazole for the treatment of life-threatening invasive fungal infections, primarily those suffered by immuno-compromised patients. Isavuconazole has orphan drug status and Qualified Infectious Disease Product (QIDP) designation in the U.S. for the treatment of invasive aspergillosis and mucormycosis. The QIDP status provides priority review and a five-year extension of market exclusivity in the U.S. apart from the seven-year exclusivity based on the orphan drug designation.

We remind investors that Astellas has exclusive rights to develop, manufacture and commercialize isavuconazole in the U.S. and Canada. Basilea holds complete rights to isavuconazole in other markets and is eligible to receive a milestone payment from partner Astellas once the FDA accepts the NDA submission.

Meanwhile, Basilea intends to file a marketing authorization application for isavuconazole in Europe, shortly.

According to the press release issued by Basilea, invasive aspergillosis occurs in approximately 5%−13% of bone marrow transplant recipients, 5%−25% of heart or lung transplant recipients and 10%−20% of intensive chemotherapy patients for leukemia. Invasive mucormycosis occurs in immunocompromised patients, including patients undergoing chemotherapy or bone marrow transplantation.

Astellas filed the NDA for isavuconazole based on positive data from phase III studies − SECURE and VITAL. Isavuconazole is currently in a third phase III study (ACTIVE), which will evaluate the safety and efficacy of isavuconazole (intravenous and oral administration) for the treatment of invasive Candida infections.

We are pleased to see Astellas' progress with its pipeline. With fast track status in the U.S., we expect isavuconazole's FDA review process to expedite.

Astellas carries a Zacks Rank #4 (Sell). Some better-ranked stocks in the health care sector include Synergy Pharmaceuticals, Inc. ( SGYP ), Endo International plc ( ENDP ) and BioCryst Pharmaceuticals, Inc. ( BCRX ). While Synergy Pharma carries a Zacks Rank #1 (Strong Buy), Endo and BioCryst hold a Zacks Rank #2 (Buy).


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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of The NASDAQ OMX Group, Inc.



This article appears in: Investing , Business , Stocks

Referenced Stocks: ALPMY , ENDP , BCRX , SGYP

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