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Alexza Pharma Says CHMP Gives Positive Opinion Recommending Grant of Marketing Authorization for ADASUVE

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Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) and Grupo Ferrer Internacional, S.A., today announced 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.  Patients should receive regular treatment immediately after control of acute agitation symptoms.  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.

The positive opinion was based on Alexza's clinical development program that included two randomized, multicenter Phase 3 pivotal studies of ADASUVE, which enrolled 344 adult patients with schizophrenia and 314 adult patients with bipolar disorder.  These two clinical trials demonstrated statistically significant reductions in agitation from baseline compared to placebo^1,2. Alexza estimates that as many as 8 million adults in the EU alone suffer from schizophrenia or bipolar disorder^3.  Agitation is a common symptom for these patients^4.

The CHMP positive opinion will now be forwarded to the European Commission, which has the authority to grant marketing authorization for medicinal products in the EU.  The marketing authorization expected to be delivered by the European Commission would be applicable in all 27 EU Member States, plus Iceland, Liechtenstein and Norway.  A decision is expected from the European Commission in the first quarter of 2013.  Alexza filed the ADASUVE Marketing Authorization Application (MAA) with the EMA in October 2011.

Posted-In: News FDA


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