Alexza Pharmaceuticals and Grupo Ferrer Interncional, S.A., announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending that ADASUVE (Staccato loxapine) be granted European Union (EU) centralized marketing authorization. The CHMP recommends that ADASUVE be authorized in the EU for the rapid control of mild-to-moderate agitation in adult patients with schizophrenia or bipolar disorder. The recommendation by the CHMP is that ADASUVE should be administered only in a hospital setting under the supervision of a healthcare professional. Short-acting beta-agonist bronchodilator treatment should be available for treatment of possible severe respiratory side-effects, such as bronchospasm.
Alexza’s clinical development program can be credited as the basis for the positive opinion. The program included two randomized, multicenter Phase 3 pivotal studies of ADASUVE, which enrolled 344 adult patients with schizophrenia and 314 adult patients with bipolar disorder. Each of the trials displayed statistically significant reductions in agitation from baseline compared to placebo. In the EU alone, an estimated 8 million adults suffer from schizophrenia or bipolar disorder and a common symptom for these patients is agitation.
“The recommendation for approval from CHMP moves us one step closer to bringing this novel treatment to patients with agitation,” said James V. Cassella, PhD, Executive Vice President and Chief Scientific Officer, Alexza Pharmaceuticals. “We believe that ADASUVE may provide an important new therapeutic option as the first rapid and non-invasive treatment to address episodes of agitation.”
The European Commission (EC) will now receive the positive opinion from the CHMP, and the EC has the authority to award marketing authorization for medicinal products in the European Union. The European Commission is expected to grant the marketing authorization to Alexza, and the authorization will be applicable in all 27 EU Member States, plus Iceland, Liechtenstein and Norway. The EC is expected to render a decision in the first quarter of 2013. Alexza initialy filed the ADASUVE Marketing Authorization Application (MAA) with EMA in October 2011.
For further information, visit www.alexza.com
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