ARTICLE | Regulation

Mild Was Enough

Final FDA backing for Benlysta may not provide roadmap for other lupus drugs

November 22, 2010 8:00 AM UTC

Leading up to last week's advisory committee meeting to discuss a BLA for lupus candidate Benlysta belimumab from Human Genome Sciences Inc., the outcome hardly looked like a slam dunk. Based on a pair of Phase III trials that met their primary endpoints but fell short on several other measures, FDA reviewers asked members of the Arthritis Advisory Committee to discuss whether the antibody's "marginal efficacy" was enough to justify potential risks suggested by small increases in cases of infections, cancer and suicides seen in trials.

It turned out neither concern overly troubled the panel, which voted 10-5 that the data demonstrated substantial evidence of efficacy and 14-1 that Benlysta's safety profile was sufficient. The final vote in favor of approval was 13-2, based largely on unmet need in an indication where a new drug has not been approved in more than 50 years...