Lupus drug ‘Benlysta’ gets thumbs up from federal health officials

Lupus drug 'Benlysta' gets FDA approval

Lupus drug Benlysta became the first medication in more than 50 years on Wednesday to get approval to treat the autoimmune condition.

The U.S. Food and Drug Administration gave the approval after an advisory panel endorsed the drug in November.

Seven other lupus drugs failed to get past through the clinical trial stage in recent years. Benlysta's approval is expected to benefit patients and encourage drug makers to develop products to treat lupus symptoms.

"It's important to the field to have an approved product," Dr. David S. Pisetsky of the Lupus Research Institute told the New York Times.

Benlysta is the first drug for Human Genome Sciences to get FDA approval. Pharmaceutical firm GlaxoSmithKline will be introducing the new lupus drug to the worldwide market.

The study which the advisory committee based its decision showed that 43.2 percent of participants who took Benlysta demonstrated a decline of symptoms of lupus. A control group receiving a placebo had a 33.8 percent reduction. In other terms, Benlysta will be effective in one in 11 lupus patients, according to FDA officials.

Benlysta will carry warning labels against use for those whose kidney function or immune system is already compromised, as it may exacerbate pre-existing conditions.

The FDA and Humane Genome Sciences agreed that the latter will conduct another trial to assess the drug's effectiveness among African-Americans. The original study did not include enough participants of African descent to determine any substantial and beneficial results among that group.

Patients who were part of the trial said fatigue, lesions and other symptoms were relieved by the new lupus drug.

Posted by George Daniels on Friday March 11 2011, 5:32 AM EST. Ref: NY Times. All trademarks acknowledged. Filed under Featured News, Health. Comments and Trackbacks closed. Follow responses: RSS 2.0