EU Panel Recommends Adasuve Approval
MOUNTAIN VIEW, Calif. (AP) — Alexza Pharmaceuticals Inc. said that a panel of European Union regulators recommended marketing approval for its drug Adasuve, an inhaled treatment for agitation in patients with schizophrenia or bipolar disorder.
The company and its partner Grupo Ferrer Internacional said the advisory panel recommended that Adasuve be approved for the control of mild to moderate agitation in adult patients. The panel recommended that patients receive regular treatment as soon as their agitation symptoms are under control, and that Adasuve be administered only at a hospital under supervision of a health care professional.
Alexza does not have any products on the market, and Adasuve is its most advanced drug candidate. If the drug is approved in Europe, the companies will be able to market it in all 27 EU countries and Iceland, Liechtenstein, and Norway. A decision on the drug is expected in the first quarter of 2013.
Privately held Grupo Ferrer is based in Barcelona, Spain.
Date: December 14, 2012
Source: Associated Press