GSK announces first European license for depression drug

GlaxoSmithKline (GSK) has announced that its depression treatment Wellbutrin XR (bupropion hydrochloride modified-release tablets) has been granted its first marketing license in Europe.

The compound has been awarded a license in the Netherlands and under the decentralised procedure is now considered approvable by the agencies of 21 other European countries.

GSK forecasts that a number of regulatory authorities in Europe will grant licenses in for Wellbutrin XR during the first quarter of the year, with the drug becoming available to patients in those countries as early as April 2007.

Andrew Witty, president of GSK Pharmaceuticals in Europe, said: “Wellbutrin XR is an important new medicine for doctors and patients in Europe.

“Depression can be a crippling condition that is often difficult to treat.”

He added that Wellbutrin XR offered a genuine alternative treatment option for patients suffering with depression, adding that it was hoped the compound would enable patients to stay on the treatment, addressing an area of unmet need regarding antidepressants.

In June 2006, the US Food and Drug Administration approved Wellbutrin XL, an extended release tablet, for the prevention of major depressive episodes in patients who have been diagnosed with seasonal affective disorder.