FDA Panel Backs Astellas Pharma Inc. (ALPMY)'s CRESEMBA for Invasive Fungal Infections
1/22/2015 7:36:47 AM
January 23, 2015
By Riley McDermid, BioSpace.com Breaking News Sr. Editor
The Anti-Infective Drugs advisory committee panel voted 11-0 on Thursday that the U.S. Food and Drug Administration approve Astellas Pharma Inc. (ALPMY)'s drug, isavuconazonium, for the treatment of rare, often fatal invasive fungal infections.
Dubbed Cresemba, the drug treats invasive aspergillosis, which can target patients with blood cancers. The Japanese drugmaker also got a designation from the FDA to treat invasive mucormycosis, a decision the panel arrived at with a vote of 8-2 with one abstention.
Invasive aspergillosis generally attacks patients with a severely compromised immune systems, a condition often caused by blood cancers like leukemia. Mucormycosis is a much more rare infection, but it can advance extremely quickly, and is very often fatal.
Even more importantly, the FDA has as part of its decision designated isavuconazonium as a Qualified Infectious Disease Product. That designation makes it eligible for a priority review and a very lucrative five-year extension of market exclusivity in the United States.
Cresemba was initially given Orphan Drug status by the FDA, a helpful incentive used by U.S. regulators to get large pharmaceutical companies to put resources into developing drugs for rare diseases—and reap the benefits of the seven years of market exclusivity provided if a drug is eventually approved.
"We're pleased with today's positive recommendation for the approval of Cresemba for both indications," said Bernie Zeiher, executive vice president of global development and therapeutic area head of infectious disease at Astellas. "We look forward to working with the FDA to bring this important new therapy to patients to address an unmet need in the treatment of these life-threatening infections."
Astellas said that the Advisory Committee made its decision based on data from two Phase III clinical trials in adult patients with invasive fungal infections: SECURE, a randomized, double-blind, active-control study of adult patients with invasive aspergillosis; and VITAL, an open-label non-comparative study of CRESEMBA in adult patients with invasive aspergillosis and renal impairment or in patients with invasive fungal disease caused by other rare fungi.
In those trials, Cresemba was just as safe and effective in reducing mortality as its closest competitor, a drug made by Pfizer Inc. (PFE) called voriconazole, which also treats aspergillosis.
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