Astellas Pharma, Inc.
) 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
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
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.
Salix Pharmaceuticals Ltd.
BioCryst Pharmaceuticals, Inc.
). While Synergy Pharma and Salix carry a Zacks Rank #1 (Strong
Buy), BioCryst holds a Zacks Rank #2 (Buy).
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