Company News: GSK and Human Genome Sciences
Human Genome Sciences today filed an FDA marketing application for Benlysta (belimumab). The drug is designed to treat systemic lupus erythematosus (SLE) and, if approved, would be the first new FDA-sanctioned product for SLE in 50 years. Barry Labinger, EVP and chief commercial officer for HGS, told MM&M last month that he is hoping for priority review of six months and that HGS is gearing up its sales and marketing efforts in preparation for a potential launch by year's end. The FDA submission includes results from two Phase III trials, one 52 weeks the other 76. Benlysta met its primary endpoint after 52 weeks but not a secondary endpoint in the 76-week trial. An analyst from Wolters Kluwer Pharma Solutions gives Benlysta a 60% chance of approval and a $1.6 billion forecast. GSK, which is sharing in the development costs as part of a co-promotion agreement, filed a marketing application in the EU earlier this month.