January 22, 2015 / 8:32 PM / 3 years ago

FDA panel backs Astellas drug for invasive fungal infections

(Reuters) - A panel of experts on Thursday voted to recommend that U.S. health regulators approve Astellas Pharma Inc’s drug for the treatment of rare, often fatal invasive fungal infections that can target patients with blood cancers.

The Anti-Infective Drugs advisory committee panel voted 11-0 that the Japanese drugmaker had demonstrated sufficient safety and efficacy to support approval of the drug, isavuconazonium to treat invasive aspergillosis.

The panel voted 8-2 with one abstention to recommend the medicine to treat invasive mucormycosis.

The Food and Drug Administration, which typically follows the recommendations of its advisory panels but is not obligated to do so, is expected to make its approval decision by March 8.

“We’re extremely excited and think this medicine will address significant unmet medical needs in both of these indications,” Bernie Zeiher, Astellas’ head of global development and immunology and infectious diseases, said in a telephone interview.

In clinical trials, the drug proved at least as safe and effective in reducing mortality as voriconazole, which Pfizer sells under the brand name Vfend, the current standard of care for aspergillosis.

The Astellas medicine, which would be sold under the proposed brand name Cresemba, was granted Orphan Drug status by the FDA, which is given as incentive to develop drugs for rare diseases and comes with seven years of market exclusivity if approved.

The FDA also designated isavuconazonium as a Qualified Infectious Disease Product, which provides for a priority review and a five-year extension of market exclusivity in the United States.

Invasive aspergillosis is a rare, life-threatening fungal infection seen predominantly in patients with compromised immune systems, such as those with leukemia. Mucormycosis is a very rare, rapidly progressing invasive fungal infection also with high rates of morbidity and mortality.

Panelists cited limitations of current medicines and the need for additional treatment options for the devastating infections in recommending the Astellas drug.

Reporting by Bill Berkrot in New York; Editing by Bernard Orr and Diane Craft

Our Standards:The Thomson Reuters Trust Principles.
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