April 20, 2010—The beneficial effects of the proposed lupus drug Benlysta ™ (belimumab) are not only present after 52 weeks, but persist through at least 76 weeks, HGS and GlaxoSmithKline reported today.
It was last July and November that the companies reported that high doses of Benlysta were statistically significantly superior to placebo in benefiting people with systemic lupus in two major 52-week clinical trials—a major advance for a chronic and potentially fatal illness which has had no new drug approved in 50 years.
Now results at 76 weeks show that Benlysta™ continues to do better for more trial participants than placebo—38.5% of patients responded to high dose Benlysta™ compared to 32.4% of those taking a placebo—but not to the point of statistical significance in what were considered secondary endpoints.
“The Lupus Research Institute is gratified to see that the benefits of this experimental lupus drug at Week 52 persisted through to Week 76 for many participants, and that no new safety issues arose over this longer time period,” said Margaret G. Dowd, president of the LRI.
“People with lupus and their families have been waiting a very long time for better treatments and a cure,” Dowd said. “Altogether, the findings on this investigational human monoclonal antibody drug —specifically the positive results of the two large Phase 3 trials reported last year—provide the basis for the first approval of a new lupus drug in half a century.”