GlaxoSmithKline says that Wellbutrin XR has been granted a marketing licence in the Netherlands, the first European approval for this version of the drug, for the treatment of adult patients with major depressive episodes.
Wellbutrin XR, a sustained-release form of bupropion which is marketed by GSK and manufactured by Canada’s Biovail Corp, is also considered approvable by the regulatory agencies of 21 other European countries and they are expected to grant national licenses for the drug throughout the first quarter. GSK added that it hopes to make the medicine available to patients from April 2007.
Andrew Witty, president, GSK Pharmaceuticals, Europe, said that Wellbutrin XR, which is the first once-daily noradrenaline dopamine reuptake inhibitor to be approved for the treatment of major depressive disorder in Europe, said “we hope its profile will help patients stay on their therapy, which would address a significant unmet need in the area of antidepressants.”
The drug is sold in the USA as Wellbutrin XL, where it has been used to treat nearly 13 million patients but the treatment is at the centre of a major dispute between Biovail and the US Food and Drug Administration. In August last year, the Canadian firm sued the agency to try and prevent the FDA from giving approval to generic versions of Wellbutrin XL from Anchen Pharmaceuticals and Impax Laboratories.
Wellbutrin XL represented almost 45% of Biovail's turnover during the third quarter of 2006, bringing in $123.3 million in sales. It licensed the compound to GSK in 2001 and gets an approximate 30% royalty rate on sales of the product.