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Alexza Reports 2011 First Quarter Financial Results and Provides Business Update
Date:5/9/2011

draft post-approval study outline.Following the REMS guidance meeting in April 2011, Alexza believes there is agreement with the FDA on the definition of the potentially "at-risk" patient population.  Additionally, Alexza and the FDA discussed key elements of screening for these "at-risk" patients, noting that no screen is 100% effective, and components to post-dosing risk mitigation in the event an "at-risk" patient receives a dose of AZ-004.  The FDA emphasized that there are two key components for a risk mitigation proposal:  i) adequacy of monitoring, via patient observation, for a period of time relative to the likely occurrence of a respiratory adverse reaction, and ii) availability of rescue medication (e.g., inhaled albuterol) should an adverse reaction occur.  Alexza will address this updated guidance from the FDA in its draft REMS proposal contained within the AZ-004 NDA resubmission.  The FDA indicated that a complete review of the proposed REMS in conjunction with the full clinical review of the resubmitted NDA will be necessary to determine whether the REMS will be acceptable.  The FDA stated it would present the AZ-004 application to an Advisory Committee.  The objective of this Advisory Committee meeting would be to discuss the proposed approach for managing the risks of AZ-004 in relationship to its patient benefits.  Alexza notes that it has not received the official FDA meeting minutes from the REMS guidance meeting.  The summaries in this release may be altered or supplemented by the information contained in the official meeting minutes.  The Company will provide further U.S. regulatory updates on AZ-004 after receipt of the official FDA minutes or other correspondence if there are material developments in such minutes or correspondence.


  • Alexza previously received notice that AZ-004 is eligible for submission of a Marketing Authorization Application (MAA) under t
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  • SOURCE Alexza Pharmaceuticals, Inc.
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