Alexza Pharmaceuticals has received preliminary feedback, the Day 80 Assessment Report, from the European Medicines Agency (EMA) regarding its Marketing Authorization Application (MAA) for Adasuve, which seeks approval for the rapid control of agitation in adult patients with schizophrenia or bipolar disorder.
The EMA’s assessment report of Adasuve (Staccato loxapine) outlines major objections pertaining to the extrapolation of the phase III study population to the intended patient population, and pulmonary safety in patients with active airways disease. The EMA gave recommendations to address these issues 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, when the Committee for Medicinal Products for Human Use (CHMP) finalizes the list of review questions, the overall conclusions of scientific data and a listing of outstanding issues.
Alexza completed a Pre-Approval Inspection of its GMP commercial manufacturing facility by the FDA in December 2011 and believes it is well prepared for the EMA inspection of its facility.