A Food and Drug Administration advisory panel Tuesday voted 13-2 to recommend approval of Benlysta, the first new drug to treat lupus in more than half a century. The FDA has set Dec. 9 as the date to make a final decision on the drug. It doesn't have to follow the advice of its advisory panels, but it generally does.
Benlysta is not a wonder drug that will provide relief to everybody with the debilitating disease, but it may provide benefits for some and allow them to taper off existing drugs, which have powerful side effects that some think are nearly as bad as the disease itself.
Systemic lupus erythematosus, commonly known as SLE or simply lupus, is a chronic inflammatory disease that occurs when the body's immune system attacks its own tissues and organs. As many as 90% of patients are women, usually in their 30s and 40s when it first strikes. No two cases of lupus are identical, but symptoms can include fatigue, fever, joint pain, stiffness and swelling, rashes, skin lesions, mouth sores, hair loss and chest pain. The disease can attack many internal organs, leading eventually to death.
Only three drugs are currently approved for treating lupus: aspirin, the steroid prednisone and the antimalarial drug hydroxychloroquine, all approved during the Eisenhower administration. All can have severe side effects. Other drugs, including the anti-rejection drugs cyclophosphamide and azathioprene, are sometimes used off label, but they can have even more serious side effects.
Benlysta is a monoclonal antibody known generically as belimumab. It was developed by Human Genome Sciences Inc. of Rockville, Md. and is being tested jointly by that company and GlaxoSmithKline. Studies released last year indicated that the drug helped about 30% of those who took it. For some reason, however, the drug does not appear to benefit African Americans, who are more susceptible to the disease than whites.
If the FDA approves Benlysta next month, it could be available early next year. The main drawback is expected to be cost. While the companies have not revealed what they expect to charge for the drug, other monoclonal antibodies on the market sell for thousands of dollars per dose.