HEALTH NEWS

Study Title:

FDA Approves Lupus Drug

Study Abstract

From Dow Jones Newswire:

The Food and Drug Administration approved a new lupus drug from Human Genome Sciences Inc. (HGSI) and GlaxoSmithKline PLC (GSK, GSK.LN), marking the first new treatment for the autoimmune disease in more than 50 years.

The drug, Benlysta, is widely expected to have annual sales eventually topping $1 billion and is the first product developed by the Rockville, Md.-based biotech to be approved. The two companies split both costs and profits from the drug, which they said would be available before the end of the month.

Glaxo shares in the U.S. were up nearly 4% after hours, while Human Genome's were halted in late trading.

The price of the drug will be about $35,000 per year for each patient, which Human Genome said was in the range of other biologic therapies used to treat other chronic autoimmune disease.

The companies have a 150 person sales force ready to sell the drug, executives said on a conference call Wednesday. Human Genome said that about 90% of the sales representatives have experience selling biologics to rheumatologists, something that may help physicians with the complicated reimbursement process around such drugs.

The companies expect to get a decision about potential marketing approval in Europe in the second half of the year. Pricing hasn't been determined for that region yet, but it will be "somewhat lower", the company said.

Benlysta is one of the most important new drugs in U.K.-based Glaxo's pipeline, and its success has produced persistent speculation that Glaxo, or another large drug maker, would acquire Human Genome.

Lupus is a chronic disease in which the body's immune system attacks healthy tissue rather than just going after invading bacteria and viruses that cause other common illnesses. Lupus can cause joint pain, organ damage and skin rashes. About 1.5 million Americans have lupus, according to the Lupus Foundation of America.

Benlysta, an intravenous infusion, is designed to treat lupus by blocking a protein known as BLyS, or the B-lymphocyte stimulator, that is elevated in people with lupus and other autoimmune diseases, and is believed to contribute to the production of cells that attack and destroy healthy tissue in the body.

The FDA said two clinical studies involving about 1,700 patients showed those treated with Benlysta and standard therapies experienced less disease activity than those not receiving the product. The agency also said the results suggested, but did not definitively establish, that some patients had a reduced likelihood of severe flares of the disease and some also had lower steroid use.

In November, a panel of outside medical experts recommended the FDA approve Benlysta with a 13 to 2 vote. Some panel members expressed concern about limited safety data and questioned if the product was less effective or even harmful in African-American patients.

Indeed, the FDA said Wednesday that African-Americans didn't appear to respond to treatment, but that there weren't enough patients in clinical studies "to reach a definite conclusion." The FDA said an additional study in African-Americans and people with African heritage will be conducted as a condition of approval.

On the call, the company noted that there are no limitations placed on the drug's use, but that caution should be used in such patients. It estimated that 20% to 30% of patients are African American.

Also, patients receiving Benlysta during clinical studies had more deaths and serious infections compared with patients not getting the drug.

Barclays Capital analyst Jim Birchenough said that the FDA's announcement about the approval "is better than expected," with highlights including a lupus population estimate of 300,000 to 1.5 million patients, and the agency making no definite conclusion on the drug's effectiveness in African Americans.

Birchenough estimates Benlysta peak sales of $2.7 billion in the U.S. and $2.3 billion overseas.