New lupus drug is first in 50 years

March 10, 2011|Associated Press

WASHINGTON — The Food and Drug Administration approved the first new drug to treat lupus in over 50 years yesterday, a milestone that could prompt development of even more effective drugs for the debilitating immune system disorder.

Known as Benlysta, the injectable drug is designed to relieve pain caused by lupus, a potentially fatal ailment in which the body attacks its own tissue and organs.

The maker, Human Genome Sciences Inc., spent 15 years developing Benlysta, which it will co-market with GlaxoSmithKline PLC. The companies estimate there are at least 200,000 lupus patients in the United States who could benefit from the drug.

But it is not a miracle drug: It worked in 35 percent of North American patients tested and was not effective for those with the deadliest form of the disease. Nor did it show positive results in African-Americans, who are disproportionately affected by lupus. The FDA said it would require another study exclusively with African-Americans.

The FDA approved the drug for systemic lupus erythematosus, the most common form. The 10-year survival rate for patients diagnosed with the illness is more than 85 percent, according to the National Institutes of Health.