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Home Industry News GlaxoSmithKline files for EU approval of new Votrient indication

GlaxoSmithKline files for EU approval of new Votrient indication

8th August 2013

GlaxoSmithKline has filed for approval of an amendment to the European marketing authorisation for its drug Votrient that would allow it to be used in a new indication.

The company has applied to the European Medicines Agency (EMA) for approval of the drug as a maintenance treatment for patients with stage II to IV ovarian, fallopian tube or primary peritoneal cancer who have not progressed after receiving first-line chemotherapy.

To date, the pazopanib-based is not approved or licensed anywhere in the world for this specification, but data from clinical trials has suggested that it could offer benefits for this patient group.

Dr Rafael Amado, head of oncology research and development at GlaxoSmithKline, said: "This EU filing, the third for pazopanib in less than five years, confirms GlaxoSmithKline's commitment to deliver our oncology pipeline. We are currently working on submission plans for other countries throughout the world."

This comes after Votrient's conditional European approval for renal cell carcinoma was converted into a full authorisation by the EMA last month.ADNFCR-8000103-ID-801622428-ADNFCR

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