Loading...
Loading...
Alexza Pharmaceuticals, Inc.
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.
Loading...
Loading...
© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
Benzinga simplifies the market for smarter investing
Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.
Join Now: Free!
Already a member?Sign in