Amgen Inc.’s anti-inflammatory medication Enbrel causes “life-threatening” side effects in children with psoriasis, U.S. regulators said in a report that cast doubt about whether the drug can win expanded approval, Bloomberg reports.
Enbrel, already used to treat adults with the skin disorder and for children and adults with arthritis, causes infections and cancers in some children, according to a staff review posted today on the Food and Drug Administration’s Web site. A panel of scientists will meet June 18 to advise whether Enbrel’s use should be extended to younger psoriasis patients.
The FDA said two weeks ago it was investigating a possible link between the class of drugs that includes Enbrel and cancers in children. Agency approval would allow the marketing of the drug for hundreds of children with moderate to severe forms of psoriasis, which affects up to 7.5 million Americans, according to the National Institutes of Health.
“Plaque psoriasis is not a life-threatening disease in childhood and complications are rare and largely psychosocial,” FDA staff said in their report.
The agency usually follows the recommendations of its advisory panels, though it isn’t required to do so.
Amgen, based in Thousand Oaks, California, rose 2 cents to $43.99 at 4 p.m. New York time in Nasdaq Stock Market composite trading. It sells the drug with Madison, New Jersey-based Wyeth, which slipped 34 cents to $43.08 at 4:01 p.m. on the New York Stock Exchange.
