Dec 14 European health regulators recommended
approval of Alexza Pharmaceuticals Inc's experimental
drug Adasuve for controlling agitation in adults with
schizophrenia and bipolar disorders, sending its shares up 24
percent before the bell.
The recommendation from the European Medicines Agency (EMA)
will now be forwarded to the European Commission, which normally
endorses recommendations within two or three months.
Adasuve is under review by the U.S. Food and Drug
Administration, which is due to make a decision by Dec. 21.
The study enrolled 344 adult patients with schizophrenia and
314 adult patients with bipolar disorder. Two late-stage studies
were conducted, and both demonstrated statistically significant
reductions in agitation compared to a placebo.
The EMA recommendation was that Adasuve should be
administered only in a hospital and under the supervision of a
Shares of the company were up 19 percent at $6.25 in
premarket trading. They closed at $5.24 on Thursday on the
(Reporting by Ben Hirschler in London and Adithya Venkatesan in
Bangalore; Editing by Sriraj Kalluvila)