GlaxoSmithKline's Votrient receives full EU approval

Pharmaceutical Company Product News

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.

“GlaxoSmithKline's renal cell carcinoma therapy Votrient has had its conditional European approval converted into a full authorisation, based on positive clinical trial data.“

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.

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