Lupus Drug Okayed by FDA Panel: Can Benlysta Help Women?

Lady Gaga performs during a stop of The Monster Ball Tour at the MGM Grand Garden Arena August 13, 2010 in Las Vegas, Nevada. Ethan Miller/Getty Images

Lady Gaga performs during a stop of The Monster Ball Tour at the MGM Grand Garden Arena August 13, 2010 in Las Vegas, Nevada.
Lady Gaga says she has lupus but no symptoms. (Ethan Miller/Getty Images)


ADELPHI, Md.(CBS/AP) For five decades, Lupus sufferers, ninety percent of whom are women, haven't had much good news.

That's how long it's been since a new drug was introduced to fight the potentially fatal ailment characterized by skin rashes, joint pain and inflammation of the kidneys and other organs.

Now, an FDA panel has declared that Benlyst, a drug from Human Genome Sciences, substantially relieves pain and flare-ups caused by lupus.

That makes it likely, although not definite that the FDA will allow the drug onto the market.

The drug is not without detractors. Several panelists voted against it. According to WebMD, some "FDA reviewers expressed concern about whether the 'somewhat marginal' effectiveness of the drug outweighs the potential increased risk of death, infection, and psychiatric effects, including suicide, associated with its use."

Also, the drug appears to be less effective after the first year of use.

Lupus affects around 1.5 million Americans, mostly women. The disease causes the body to attacks its own tissue and organs. In many cases, the symptoms can be treated with steroids, and non-steroidal anti-inflammatory drugs like aspirin and ibuprofen. Extreme cases are sometimes treated with immunosuppressive drugs. All current treatments have significant side effects and doctors are always walking a tight rope between symptoms and the side effects.

There is no cure.


  • Neil Katz

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