Tags: Advisory | Panel | Human | Genome | Lupus | Drug

US Advisory Panel Backs Human Genome Lupus Drug

Wednesday, 17 Nov 2010 02:50 PM

A highly anticipated lupus treatment from Human Genome Sciences Inc. moved closer to the U.S. market with an endorsement from a government advisory panel.

Benlysta could become the first medicine in a half-century to win approval for fighting the debilitating and potentially fatal autoimmune disease. Annual global sales are forecast at $2.2 billion by 2014, according to Thomson Reuters.

That would transform unprofitable biotech Human Genome into an industry star.

The company would split Benlysta profits with partner GlaxoSmithKline PLC.

A Food and Drug Administration advisory panel voted 13-2 to recommend approval of Benlysta. Supporters said the medicine helped ease symptoms with acceptable risks.

"The efficacy is mild, but I think there is a need for drug even with mild efficacy," said panel member Dr. Lenore Buckley, a professor of internal medicine and pediatrics at Virginia Commonwealth University.

The FDA usually follows panel recommendations when deciding whether to approve new medicines. A final FDA ruling is due by Dec. 9.

Human Genome argued the intravenous drug was an important advance for fighting lupus, a disease that causes the immune system to attack the body's own tissue and organs. That can lead to arthritis, kidney damage, chest pain, fatigue, skin rash and other problems. Organ damage can be fatal, and current treatments have severe side effects.

FDA reviewers, however, suggested Benlysta might have only a modest effect on lupus symptoms and might raise the risk of death, infection, or psychiatric problems including suicide. Two patients treated with Benlysta during clinical trials killed themselves and there were no suicides with a placebo.

© 2017 Thomson/Reuters. All rights reserved.

   
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A highly anticipated lupus treatment from Human Genome Sciences Inc. moved closer to the U.S. market with an endorsement from a government advisory panel. Benlysta could become the first medicine in a half-century to win approval for fighting the debilitating and...
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Wednesday, 17 Nov 2010 02:50 PM
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