GlaxoSmithKline’s new lupus drug Benlysta has showed positive results in the second of two phase III trials, following earlier trials that surpassed the companies expectations. Benlysta is aimed at inhibiting the immune system’s response to lupus.
The findings from the newest clinical test were not quite as conclusive as those from the first study but still were good enough to secure approval from regulators and ensure doctors use the drug widely, industry analysts said on Monday. The next step is to submit the drug to the Food and Drug Administration. If authorized, Benlysta could be on the market in late 2010.
The study data from a clinical program called Bliss-76, showed a 10-milligram dose of Benlysta, plus therapy with steroids, prompted an improvement in 43 percent of patients, compared with an improvement in only 33 percent of patients on the placebo end of the study.
There have been no new drugs approved in more than 50 years for SLE, the most common form of lupus, which impacts an approximated 160,000 Americans and as many as 5 million around the world. Lupus is an autoimmune disorder in which the body’s immune system attacks its own tissues and organs, causing a number of symptoms, including arthritis, kidney damage, chest pain, fatigue and a characteristic skin rash that some early doctors thought resembled wolf bites (”lupus” means wolf in Latin).
The news sent Human Genome’s shares up 35%, adding US$1-billion to its market value and turning the once unloved company into the hottest biotech story of the year.