Astellas Pharma, Inc.’s (ALPMY) isavuconazole received Qualified Infectious Disease Product (:QIDP) designation from the FDA for the treatment of invasive candidiasis. The QIDP status means that isavuconazole will get priority review besides enjoying a five-year extension of market exclusivity in the U.S., post-approval.
Isavuconazole is being jointly developed by Astellas and Basilea Pharmaceutica Ltd. Currently, isavuconazole is in the phase III ACTIVE study, which is the third study in a phase III program on the candidate. In this study Astellas will evaluate the safety and efficacy of isavuconazole (intravenous and oral administration) for the treatment of invasive Candida infections.
Invasive candidiasis is a nosocomial infection (contracted by patients while they are under medical care) that frequently occurs in critically ill patients including cancer patients undergoing chemotherapy, organ transplantation or invasive surgical procedures, and is associated with high mortality. According to the press release issued by Basilea, infections caused by Candida yeasts are the fourth and seventh most common cause of bloodstream infections in the U.S. and Europe, respectively.
We note that isavuconazole also has QIDP designation in the U.S. for the treatment of invasive aspergillosis and mucormycosis (also known as zygomycosis). Additionally, isavuconazole has orphan drug status in the U.S. and Europe for the treatment of invasive aspergillosis and mucormycosis.
Meanwhile, Basilea has submitted a marketing authorization application for isavuconazole in Europe for the treatment of invasive aspergillosis and mucormycosis.
We are encouraged by the fact that Astellas now has QIDP designation for isavuconazole for three indications. Given the rising number of immunocompromised patients who are at risk for developing invasive fungal infections, we believe there is an urgent need for new antifungal therapies.
Last week, Astellas announced that it has filed a new drug application with the FDA for isavuconazole for the treatment of invasive aspergillosis and mucormycosis. 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), Salix Pharmaceuticals Ltd. (SLXP) and BioCryst Pharmaceuticals, Inc. (BCRX). While Synergy Pharma and Salix carry a Zacks Rank #1 (Strong Buy), BioCryst holds a Zacks Rank #2 (Buy).
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