The Wall Street Journal is reporting that the Food and Drug Administration approved a new lupus drug from Human Genome Sciences Inc. and GlaxoSmithKline PLC, 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 percent 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 diseases.
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. The condition can cause joint pain, organ damage and skin rashes. About 1.5 million Americans have lupus, according to the Lupus Foundation of America.
In November, a panel of outside medical experts recommended that the FDA approve Benlysta with a 13-2 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.
The FDA said Wednesday that African Americans didn't appear to respond to treatment, but there weren't enough patients in clinical studies "to reach a definite conclusion." The FDA said an additional study of African Americans and people with African heritage would 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 percent to 30 percent of patients are African American.
It took 50 years to get a new drug to treat lupus introduced to the market, and it may be harmful to African Americans? Black women are three times more likely to develop the disease. We also are diagnosed with it at a younger age and have more severe symptoms than whites. Naturally, the drug companies would spend 50 years developing a drug that helps white patients and may not be helpful to African Americans. And what does that mean for Native Americans, who also suffer disproportionately from the disease? Is there a drug being developed for our populations?
Read more at the Wall Street Journal.
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