Astellas Pharma, Inc.
) 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
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.
Endo International plc
BioCryst Pharmaceuticals, Inc.
). While Synergy Pharma carries a Zacks Rank #1 (Strong Buy), Endo
and BioCryst hold a Zacks Rank #2 (Buy).
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