Alexza Pharmaceuticals says that the Day 80 Assessment Report it has received from the European Medicines Agency (EMA) regarding its Marketing Authorization Application (MAA) for Adasuve Staccato loxapine indicates that the report “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.”
Adasuve is an inhaled loxapine product for the treatment of agitation in adults with schizophrenia or bipolar disorder delivered using Alexza’s proprietary Staccato inhaler. Alexza, which is partnered with Grupo Ferrer for Adasuve in the EU, filed the MAA in October 2011. In the US, the FDA recently announced an extension of its review of the Adasuve NDA.
According to Alexza, the FDA completed a Pre-Approval Inspection of the manufacturing facility for Adasuve in December 2011, and the company says it “believes it is well prepared for the EMA inspection of its facility.”
Read the Alexza press release.
