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
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