GlaxoSmithKline receives European approval for Benlysta
15 July 2011 00:00 in Pharmaceutical Company Product News
GlaxoSmithKline has been granted approval from the European Commission for Benlysta, its new treatment for systemic lupus erythematosus (SLE).
In association with partner Human Genome Sciences, the company has won authorisation for the drug to be marketed as an add-on therapy in adult patients with active autoantibody-positive SLE.
This comes after the treatment was approved in the same indication in the US and Canada earlier this year, with further regulatory reviews currently taking place worldwide.
Dr Tony Hoos, senior vice-president for European medical affairs at GlaxoSmithKline, said this latest approval represents a "significant milestone".
He added: "We are very pleased to be able to provide physicians an additional therapeutic option for treating appropriate patients with this chronic disease."
Earlier this month, the company submitted an application for Votrient to be approved as an advanced soft tissue sarcoma in the EU and US.
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