Alexza (ALXA) Gets Day 80 AR from EMA for Adasuve MAA
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Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) has received preliminary feedback, the Day 80 Assessment Report, from the European Medicines Agency (EMA) regarding its Marketing Authorization Application (MAA) for Adasuve™ (Staccato® loxapine). The ADASUVE MAA seeks approval for the rapid control of agitation in adult patients with schizophrenia or bipolar disorder.
The Day 80 Assessment Report for ADASUVE outlines major objections pertaining to the extrapolation of the Phase 3 study population to the intended patient population, pulmonary safety in patients with active airways disease and recommendations to address this issue via the risk management plan, other aspects of the risk management plan, and the need to obtain an EU GMP certificate for the Alexza manufacturing facility and commercial manufacturing process. The next official EMA communication Alexza expects to receive will be the Day 120 notification and report, where the CHMP finalizes the list of review questions, the overall conclusions of scientific data and a listing of outstanding issues.
The ADASUVE MAA was filed using the Centralized Procedure. The Day 80 assessment report provides initial questions drafted by the Rapporteur and Co-Rapporteur, and is prepared for distribution to the EMA's Committee for Medicinal Products for Human Use (CHMP) members. The EMA provides this assessment report to the applicant for information only, as it contains preliminary conclusions and does not represent the position of the CHMP nor does it bind the CHMP in any way.
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The Day 80 Assessment Report for ADASUVE outlines major objections pertaining to the extrapolation of the Phase 3 study population to the intended patient population, pulmonary safety in patients with active airways disease and recommendations to address this issue via the risk management plan, other aspects of the risk management plan, and the need to obtain an EU GMP certificate for the Alexza manufacturing facility and commercial manufacturing process. The next official EMA communication Alexza expects to receive will be the Day 120 notification and report, where the CHMP finalizes the list of review questions, the overall conclusions of scientific data and a listing of outstanding issues.
The ADASUVE MAA was filed using the Centralized Procedure. The Day 80 assessment report provides initial questions drafted by the Rapporteur and Co-Rapporteur, and is prepared for distribution to the EMA's Committee for Medicinal Products for Human Use (CHMP) members. The EMA provides this assessment report to the applicant for information only, as it contains preliminary conclusions and does not represent the position of the CHMP nor does it bind the CHMP in any way.
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