UPDATE 2-Astra drug recommended in EU for some depression

* European agency backs Seroquel XR as add-on treatment

* Move follows rebuff from Dutch authorities last year

(Adds detail on drug, EU approval process)

LONDON, April 23 (BestGrowthStock) – AstraZeneca’s (AZN.L: ) schizophrenia drug
Seroquel XR has been recommended by European regulators as an add-on treatment
for depression, following an earlier rebuff in the Netherlands.

The European Medicines Agency said on Friday it could help patients with
major depressive disorder who have had sub-optimal response to treatment with
other antidepressants.

The decision is in line with approval for the drug granted by the U.S. Food
and Drug Administration in December and will come as a relief to AstraZeneca.

Last May, the Dutch authorities, acting as reference member state under the
European Union’s mutual recognition procedure, rejected Seroquel XR in
depression, prompting AstraZeneca to refer its application to the European
Medicines Agency, which approves drugs centrally.

Seroquel XR is an extended release version of AstraZeneca’s original
blockbuster medicine Seroquel, which the company hopes will win increasing
market share as the older drug faces patent expiry.

It is already used for bipolar disorder and schizophrenia, though it has
side effects including weight gain and a movement disorder called tardive
dyskinesia.

Adding major depression would boost sales, since the drug could help
patients who do not respond well to conventional antidepressants. But its
commercial potential in this new area will be limited if it can be used only as
an adjunct to other drugs rather than as a monotherapy.

Recommendations for marketing approval by the EU agency’s Committee for
Medicinal Products for Human Use (CHMP) are normally endorsed by the European
Commission within a couple of months.

Stock Report

(Reporting by Ben Hirschler, editing by Will Waterman and Rupert Winchester)

UPDATE 2-Astra drug recommended in EU for some depression