FDA Approves First New Lupus Drug In More Than 50 Years

Score one for Team Genome.

The Food and Drug Administration just approved a lupus drug called Benlysta, whose roots go back to 1996, when the genome gold rush was in full swing.

Most of the hype back then — about how deciphering the human genetic code would quickly usher in a slew of amazing new drugs — hasn't panned out. But Benlysta is one example where the genomic prospecting paid off.

The medicine, which will cost about $35,000 a year, is a bioengineered antibody that calms overactive B cells, white blood cells that produce antibodies. In lupus, the immune system attacks a person's body as if it's a foreign invader. Benlysta was approved to treat systemic lupus erythematosus (SLE) in people who test positive for self-destructive antibodies.

Benlysta is shaping up as the first blockbuster drug from Human Genome Sciences, a pioneer in using genes to search for new medicines. GlaxoSmithKline will help sell it.

There are side effects, of course, and some of them are pretty serious. In clinical tests involving about 2,100 people, 11 taking Benlysta died compared with 4 getting placebo. About 6 percent of people taking Benlysta got serious infections compared with 5.2 percent on placebo.

Benlysta was approved to treat only one form of lupus, SLE, and it's supposed to be used in combination with standard therapies, such as steroids. Benlysta is the first new lupus medicine approved by FDA in 56 years.

As a reporter at the Wall Street Journal, I covered Human Genome Sciences for years, and I had figured the company's first big drug on the market would be a version of interferon, rejiggered to last longer in the body, as a treatment for hepatitis C. The medicine, which wasn't part of the company's gene-based drug program, looked like a less risky bet because it was essentially a tweak to an already approved drug.

But the FDA rejected the company's application for approval last October, and Human Genome Sciences and Novartis, a partner in the drug's development, decided to drop the project altogether.

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