LONDON (Alliance News) - GlaxoSmithKline PLC Wednesday said it had withdrawn its European marketing authorisation application for the combined use of Meikinist and Tafinlar for the treatment of unresectable or metastatic melanoma with a BRAF V600 mutation.
This was as a result of the Committee for Medicinal Products for Human Use within the European Medicines Agency indicating that the data provided by Glaxo had not allowed it to conclude on a benefit of the combined treatment.
Glaxo said that it will re-submit its application for the combined treatment when it has further data from its ongoing Phase III programme.
The application for Mekinist for use as a single agent is still undergoing review with the European Medicines Agency.
"Although we have withdrawn our application, we remain committed to providing further data from our ongoing Phase III development programme to support a subsequent re-submission in Europe," said Rafael Amado, head of oncology research and development.
Also on Wednesday, Glaxo said that its once-weekly type 2 diabetes treatment Eperzan had been granted marketing authorisation by the European Commission. It expects to launch the product in several countries in Europe in the third and fourth quarter of 2014, with additional launches to follow.
The treatment is currently under review by the US Food and Drug Administration, amongst other authorities.
Shares in Glaxo were trading up 0.2% at 1,625.00 pence Wednesday afternoon.
By Hana Stewart-Smith; hanassmith@alliancenews.com; @HanaSSAllNews
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