FDA OKs lupus drug Benlysta

WASHINGTON -- The Food and Drug Administration approved the first new drug to treat lupus in over 50 years, a milestone that medical experts say could prompt development of other drugs that are even more effective in treating the debilitating immune system disorder.

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

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

But experts stress that Benlysta is not a miracle drug: It only worked in 35 percent of North American patients tested and was not effective for patients with the deadliest form of the disease. Additionally, it did not show positive results in African-Americans, who are disproportionately affected by lupus. The FDA said in its news release it would require the drug developers to conduct another study exclusively in African-Americans.

The FDA approved the drug for systemic lupus erythematosus, the most common form of the disease. Lupus causes fibrous tissue and inflammation of internal organs, skin rashes and joint pain.

Most patients treat their disease with a variety of drugs that help ease inflammation, including painkillers, steroids and antimalarial drugs -- which were first approved for lupus in the 1950s. ---- AP