First new lupus drug in over 50 years: Benlysta

Human Genome Sciences and GlaxoSmithKline announced that an Food and Drug Administration (FDA) advisory panel Tuesday voted 13-2 to recommend approval of Benlysta, a new drug to treat lupus. This is likely to lead to full regulatory approval next month.

Benlysta is one of the most important new drugs for GlaxoSmithKline and Human Genome Sciences and is expected to be a blockbuster for the pharmaceutical giants, with forecast sales of $2.2 billion by 2014.

In a statement commenting on the panel’s vote, Margaret Dowd, president and CEO of the Lupus Research Institute, said that “we couldn’t be more pleased. It’s a historic day for the lupus community.”

One of the committee members for the FDA advisory panel last week had raised questions regarding Benlysta’s benefits and noted associations with adverse events including some suicides. Questions were also asked about the clinical data presented, taking note that one of the two key trials did not include patients in the U.S.

Lupus impacts approximately 1.5 million Americans, generally women. The disease causes the body to attack its own tissue and organs. Lupus can cause skin rashes, joint pain and inflammation of the kidneys and other organs. In many cases, the symptoms can be treated with steroids, and non-steroidal anti-inflammatory drugs like aspirin and ibuprofen. The more serious cases are occasionally 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.

The FDA is expected to make a final decision on Benlysta by December 9 of this year. If given a green light, Benlysta will become the first new drug specifically for lupus to hit the market in over 50 years.