GSK and HGS secure regulatory clearance for Benlysta

Staff in regulatory affairs jobs at GlaxoSmithKline (GSK) and Human Genome Sciences (HGS) have won approval for the new drug Benlysta in Europe.

The European Commission has granted marketing authorisation for the product to be used as an add-on therapy for adult patients with active autoantibody-positive systemic lupus erythematosus.

It is designed for those whose continue to experience a high level of disease activity, as manifested by a positive anti-dsDNA and a low complement, despite receiving standard therapy.

Benlysta received approval from US healthcare regulators in March 2011, with Health Canada also ratifying the treatment this month.

H Thomas Watkins, president and chief executive officer for HGS, said: "We are particularly honoured to be bringing this medicine forward in Europe, where a number of key academic research institutions were very important to its clinical development."

Last month, GSK received a provisional recommendation from the National Institute for Health and Clinical Excellence for its drug Trobalt to be prescribed to epilepsy patients.

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