The first new treatment for lupus in a half-century won U.S. approval on Wednesday, a milestone for patients with the disabling disease and a potential blockbuster for its tiny biotech maker.
Health officials cleared Benlysta, discovered by Human Genome Sciences Inc, to combat the disease that causes the immune system to attack joints and organs and has proved tough to study and treat.
Shares of Human Genome, a money-losing company founded in 1992 to develop drugs with data from the human genetic map, were halted. The company will split profits with British drug giant GlaxoSmithKline Plc.
Glaxo shares rose 3.4 percent in after-hours trading to $39.90, up from an earlier close of $38.58 in regular trading on the New York Stock Exchange. Benlysta's annual global sales may top $3 billion in 2015, according to Thomson Reuters consensus forecasts. Some analysts predict sales as high as $5 billion in later years.
For doctors and patients, Benlysta is a welcome advance after decades with few good options and a string of research failures.
"It is a big success. It opens the way for more FDA-approved lupus drugs," Dr. Anca Askanase of the New York University School of Medicine and the NYU Hospital for Joint Diseases said in an interview.
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