Human Genome Sciences Inc. said on Monday its experimental drug to treat lupus was successful in a late-stage clinical trial, a likely shock to many on Wall Street who had written the drug off as dead.
The results, which were announced just after midnight on Sunday, showed patients who took the drug, Benlysta, showed a statistically significant improvement in the symptoms of their disease compared to those taking a placebo.
Results of the 52-week trial -- the first of two requested by U.S. regulators -- showed 57.6 percent of patients taking a high dose of Benlysta experienced an improvement in their symptoms, compared with 43.6 percent who took a placebo, Reuters reports.
"This is just a wonderful outcome, we're delighted," said David C. Stump, HGS's head of drug development. "Patients have been looking for a new medication for 50 years."
If the next round of tests go well, HGS plans to file for Food and Drug Administration approval early next year. The drug could become available late in 2010. The company has not determined how much it will charge for the treatment, Washington Post reports.
Meanwhile, study results showed that Benlysta, generically belimumab, combined with standard of care "achieved a clinically and statistically significant improvement in patient-response rate at week 52, compared with standard of care alone." The drug was generally well tolerated with adverse events occurring at rates comparable to those of the groups treated with placebo, the drugmakers, based in Rockville, Md., and the UK respectively, said. They formed the partnership to develop the drug in August 2006, MarketWatch reports.