GlaxoSmithKline and Human Genome Sciences' lupus drug Benlysta, which is widely expected to become a blockbuster, has been given the thumbs-up by regulators in Europe.
The European Commission has granted marketing authorisation for Benlysta (belimumab) as an add-on therapy in adults with active autoantibody-positive systemic lupus erythematosus, "with a high degree of disease activity despite standard therapy". The green light comes a couple of days after Canada approved the drug, while the US Food and Drug Administration backed the treatment in March.
Tony Hoos, head of European medical affairs at GSK, said that the latest approval "represents a significant milestone, and we are very pleased to be able to provide physicians an additional therapeutic option for treating appropriate patients with this chronic disease". HGS chief executive Thomas Watkins added that "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".
Analysts believe that Benlysta, the first new drug for lupus in 50 years, is going to be a blockbuster with sales in the region of $2-$3 billion. The drug is also under review in Australia, Switzerland, Russia, Brazil, the Philippines, Israel, Singapore, Taiwan and Colombia.