Alexza Pharmaceuticals Inc. (ALXA) said that the Psychopharmacologic Drugs Advisory Committee or PDAC of the U.S. Food and Drug Administration voted to recommend that ADASUVE be approved for use as a single dose in 24 hours when used with the FDA recommended Risk Evaluation and Mitigation Strategy or REMS, for the treatment for agitation in patients with schizophrenia or bipolar mania.
Thomas King, President and Chief Executive of Alexza Pharmaceuticals said, "We appreciate the Advisory Committee's recognition of agitation as a serious and underappreciated symptom of schizophrenia and bipolar disorder. If approved, we believe ADASUVE represents a valuable treatment option for patients and physicians alike."
The ADASUVE NDA Prescription Drug User Fee Act or PDUFA goal date is February 4, 2012, as announced earlier. In Europe, a Marketing Authorization Application or MAA for ADASUVE is currently under review by the European Medicines Agency or EMA and the application would follow the Centralized Procedure.
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