Rheumatologists have expressed a high level of interest in Benlysta, a new therapy to treat systemic lupus erythematosus (SLE) currently being reviewed by the US Food and Drug Administration.
No new lupus drugs have been approved for half a century.
According to a BioTrends Research Group survey involving 102 US rheumatologists, current SLE therapies are effective, but there are major concerns about their side effects.
Benlysta, developed by Human Genome Sciences and GlaxoSmithKline, is a first-in-class BLyS-specific inhibitor that uses a unique mechanism of action and has shown a favourable safety profile.
The drug has successfully met its primary endpoint in two Phase III trials in seropositive patients with SLE.
The efficacy of treatment with Benlysta plus standard of care was shown to be superior to placebo plus standard of care.
A marketing authorisation application was also submitted to the European Medicines Agency in June 2010.