As monoclonal antibodies continue to prove a hot prospect for alliances some news that will enhance this trend comes from the achievement of a monoclonal antibody co-development and co-commercialisation alliance between Human Genome Sciences and GlaxoSmithKline. On November 1 2009 the two companies announced that their monoclonal drug Benlysta (belimumab) had statistically improved the treatment of patients with systematic lupus erythematosus (SLE) and had the potential to become the first new approved drug in fifty years for people living with the disease. The two companies are planning to submit marketing applications for the drug in the first half of 2010, following discussions with regulatory authorities in the United States, Europe and other regions.
The companies indicated that the investigational drug had met the primary endpoint in BLISS-76, the second of two pivotal Phase 3 trials in seropositive patients with SLE. Conducted for 52 weeks the BLISS-76 study results showed that belimumab 10 mg/kg plus standard of care achieved a statistically significant improvement in patient response rate as measured by the SLE Responder Index at Week 52, compared with placebo plus standard of care. Study results also showed that belimumab was generally well tolerated, as demonstrated by a similar rate of discontinuations due to adverse events across treatment groups, with overall adverse event rates comparable between belimumab and placebo treatment groups. More data will be available following completion of the full 76-week study period.
