Alexza Pharmaceuticals, Inc. (ALXA) and Grupo Ferrer Internacional, S.A., announced that the Committee for Medicinal Products for Human Use, or CHMP, of the European Medicines Agency adopted a positive opinion recommending that ADASUVE be granted European Union centralized marketing authorization.
The CHMP recommends ADASUVE be authorized in the EU for the rapid control of mild-to-moderate agitation in adult patients with schizophrenia or bipolar disorder.
The CHMP positive opinion will now be forwarded to the European Commission. The company expects a decision from the European Commission in the first quarter of 2013.
Alexza filed the ADASUVE Marketing Authorization Application with the European Medicines Agency in October 2011.
by RTT Staff Writer
For comments and feedback: email@example.com