Alexza Pharmaceuticals Inc. (ALXA) gained the most in four months after the European Union drug regulator recommended the company’s schizophrenia and bipolar disorder medicine for approval.
The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended Alexza’s Adasuve be marketed in the EU for the rapid control of mild-to-moderate agitation in adult patients with schizophrenia or bipolar disorder, the company said today in a statement. The European Commission is expected to make a decision on marketing approval by the first quarter of 2013, according to the statement.
“We believe that Adasuve may provide an important new therapeutic option as the first rapid and non-invasive treatment to address episodes of agitation,” James Cassella, executive vice president and chief scientific officer of Alexza, said.
The committee also recommended the drug only be administered in a hospital setting under the supervision of a health-care professional.
The agency’s recommendations are the final stage before the European Commission, the EU’s executive arm, approves or rejects a drug for sale to patients in the 27-nation region. The commission usually follows the EMA’s recommendation.
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