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Home Industry News GlaxoSmithKline’s Votrient receives full EU approval

GlaxoSmithKline’s Votrient receives full EU approval

11th July 2013

GlaxoSmithKline has announced that its renal cell carcinoma drug Votrient (pazopanib) has received a full marketing authorisation from the European Medicines Agency (EMA).

The drug was granted a conditional licence in the EU in June 2010, with the regulator requesting that GlaxoSmithKline carry out a non-inferiority study to evaluate the efficacy and safety of Votrient versus Pfizer's Sutent.

Results from this study, Comparz, were announced last year and revealed that GlaxoSmithKline's drug can offer similar progression-free survival benefits to Sutent, as well as demonstrating a strong safety profile.

The European Commission subsequently ratified the decision to grant full approval to Votrient last month.

Erik van Snippenberg, general manager of GlaxoSmithKline UK, said: "GlaxoSmithKline is delighted that the EMA has lifted the conditional nature of pazopanib's licence. This is based on the strength of the Comparz head-to-head results."

This comes after the company received recommendations from Europe's Committee for Medicinal Products for Human Use for approval of its new cancer drugs Tafinlar and Tyverb last month.ADNFCR-8000103-ID-801610915-ADNFCR

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