Palm Beach, FL 12/13/11 (StreetBeat) -- Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) announced today that the Psychopharmacologic Drugs Advisory Committee (PDAC) of the U.S. Food and Drug Administration (FDA) voted to recommend that ADASUVE™ (Staccato® loxapine) be approved for use as a single dose in 24 hours when used with the FDA recommended Risk Evaluation and Mitigation Strategy (REMS), for the treatment for agitation in patients with schizophrenia or bipolar mania. The vote on this question was 9/8/1 (yes/no/abstain)."We view the recommendations by the PDAC today as another step forward in the development of ADASUVE," stated Thomas B. King , President and Chief Executive Officer of Alexza Pharmaceuticals. "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. We look forward to continuing to work toward our goal of bringing ADASUVE to market in 2012."
As previously announced, the ADASUVE NDA Prescription Drug User Fee Act (PDUFA) goal date is February 4 , 2012. In Europe, a Marketing Authorization Application (MAA) for ADASUVE is currently under review by the European Medicines Agency (EMA) and the application will follow the Centralized Procedure.
Summary of Advisory Committee Voting
The FDA takes the committee's advice into consideration as part of its review of a New Drug Application, but is not bound by an advisory committee's recommendations. After reviewing and discussing the ADASUVE data, the committee voted on the following questions:
Does the committee conclude that ADASUVE (loxapine) inhalation powder has been shown to be effective as a treatment for agitation in patients with schizophrenia or bipolar mania? The resulting vote was: 17/1/0 (yes/no/abstain).
Does the committee conclude that ADASUVE (loxapine) inhalation powder has been shown to be acceptably safe for use as a treatment for agitation in patients with schizophrenia or bipolar mania:
a. When used in conjunction with the REMS proposed by the sponsor? The resulting vote was: 1/17/0 (yes/no/abstain).
b. When used in conjunction with the REMS proposed by the FDA? The resulting vote was: 5/12/1 (yes/no/abstain).
Does the committee conclude that ADASUVE (loxapine) inhalation powder would be acceptably safe for use as a single dose in 24 hours as a treatment for agitation in patients with schizophrenia or bipolar mania:
a. When used in conjunction with the REMS proposed by FDA? The resulting vote was: 11/5/2 (yes/no/abstain).
Does the committee conclude that ADASUVE (loxapine) inhalation powder should be approved for use as a single dose in 24 hours when used with the FDA recommended REMS, for the treatment for agitation in patients with schizophrenia or bipolar mania. The resulting vote was: 9/8/1 (yes/no/abstain).
No comments:
Post a Comment