U.S. FDA approves new lupus drug

15:45, March 10, 2011      

Email | Print | Subscribe | Comments | Forum 

The U.S. Food and Drug Administration (FDA) on Wednesday approved Benlysta (belimumab) to treat patients with active, autoantibody-positive lupus who are receiving standard therapy and nonsteroidal anti-inflammatory drugs.

Prior to Benlysta, FDA approved drugs to treat lupus, Plaquenil (hydroxychloroquine) and corticosteroids, in 1955. Aspirin was approved to treat lupus in 1948.

Benlysta is delivered directly into a vein (intravenous infusion) and is the first inhibitor designed to target B-lymphocyte stimulator protein, which may reduce the number of abnormal B cells thought to be a problem in lupus.

"Benlysta, when used with existing therapies, may be an important new treatment approach for health care professionals and patients looking to help manage symptoms associated with this disease," said Curtis Rosebraugh, director of the Office of Drug Evaluation II in the FDA's Center for Drug Evaluation and Research.

Two clinical studies involving 1,684 patients with lupus demonstrated the safety and effectiveness of Benlysta. Patients treated with Benlysta and standard therapies experienced less disease activity than those who received a placebo and standard of care medicines. Results suggested, but did not definitively establish, that some patients had a reduced likelihood of severe flares, and some reduced their steroid doses.

The most common side effects in the studies included nausea, diarrhea, and fever. Patients also commonly experienced infusion reactions, so pre-treatment with an antihistamine should be considered.

Human Genome Sciences Inc., based in Rockville, Maryland, developed Benlysta and will co-market the drug in the United States with GlaxoSmithKline of Philadelphia.

Lupus is a serious, potentially fatal, autoimmune disease that attacks healthy tissues. It disproportionately affects women, and usually develops between ages 15 and 44. The disease affects many parts of the body including the joints, the skin, kidneys, lungs, heart and the brain.

When common lupus symptoms appear they can present as swelling in the joints or joint pain, light sensitivity, fever, chest pain, hair loss and fatigue.

Estimates vary on the number of lupus sufferers in the United States ranging from approximately 300,000 to 1.5 million people, according to the FDA.

Source: Xinhua

 
 
  Weekly review  
 
 
 
     
 
 

(Editor:燕勐)

  • Do you have anything to say?

双语词典
dictionary

  
Special Coverage
  • Survey for 2011 NPC and CPPCC Sessions
  • Focus On China
Major headlines
Editor's Pick
  • Int'l Auto Industry Exhibition held in Haikou
  • Hillary Clinton hopes 2011 APEC Forum to yield lasting benefits
  • Int'l cosmetics fair kicks off in Guangdong
  • Early winners at All England Open
  • Schools resume classes in Tripoli, Libya
  • Int'l Tourism Exchange trade show kicks off in Berlin
Hot Forum Dicussion