By Michael Fitzhugh
Human Genome Sciences (HGSI) and GlaxoSmithKline (NYSE:GSK) have won a crucial victory at the U.S. Food and Drug Administration, where a panel of medical experts voted in favor of recommending that the agency approve Benlysta, the company’s experimental lupus medicine.
The 13-2 vote carries Benlysta a step closer to approval and beyond investor fears that initial questions of safety and efficacy identified in an FDA report posted prior to the meeting would derail its chances of a positive panel vote.
The agency’s Arthritis Advisory Committee discussed several issues raised in the pre-meeting brief, including questions of Benlysta’s efficacy in heading off the damage lupus can wreak on important bodily organs, whether the drug is as effective for African Americans as it is for other racial groups, and inconsistent efficacy trends across different geographical regions. They also discussed the drug’s long-term effectiveness and the company’s analysis of its clinical trial data.
The Lupus Foundation of America estimates that 1.5 million Americans and at least five million people worldwide have a form of lupus, a disease in which the immune system attacks healthy cells causing inflammation and tissue damage throughout the body.
The foundation called the vote “historic,” noting that could become the first new lupus drug to be cleared by the agency in 52 years.
If approved, Benlysta could be prescribed for many of the 200,000 U.S. patients with moderate to severe systemic lupus, the most common form of the disease. A mean analyst estimate predicts that peak sales of the drug could reach $4.1 billion.
Human Genome, which has collaborated on the drug with GSK since 2006, has already hired its sales force and sales management team for the drug in the United States.
The FDA anticipates ruling on approval of Benlysta by December 9.