The FDA's dermatologic and ophthalmic drugs advisory committee spent yesterday weighing Enbrel's benefits and risks, including the risk of serious infections and cancer risk.
At the end of the day, the committee voted 8-5 to recommend that the FDA approve Enbrel to treat moderate to severe plaque psoriasis in children and teens who haven't responded to other psoriasis treatments.
The FDA hasn't decided whether to follow that recommendation; it isn't required to do so.
If the FDA sides with its advisory committee, Enbrel would be the first systemic drug - meaning it goes into the body, not just on the skin - approved to treat plaque psoriasis in pediatric patients.
Plaque psoriasis symptoms include patches of red, inflamed skin, often covered with loose, silvery scales.
Enbrel, given weekly by injection, isn't a new drug. It was first approved by the FDA in 1999 to treat rheumatoid arthritis in adults; the FDA later approved it to treat certain other arthritic conditions, including juvenile rheumatoid arthritis, which is now called juvenile idiopathic arthritis, in patients aged 2 and older.
Enbrel's Clinical Trial
Amgen and Wyeth Pharmaceuticals, the drug companies that market Enbrel in the U.S., conducted a clinical trial of 211 pediatric patients with plaque psoriasis.
During the four-month trial, adverse events - including increased rates of infection in patients taking Enbrel - were in line with previous studies in adults. No malignancies were reported. In its application to the FDA, Amgen proposes extending the study for five years to further evaluate the drug's safety.
Earlier this month, the FDA announced that it's investigating whether cancers in about 30 children and young adults are linked to the use of Enbrel, Remicade, Humira, and Cimzia, which make up a class of drugs called tumor necrosis factor (TNF) inhibitors.
In May, Enbrel got a "black box warning," the FDA's sternest warning, about the risk of serious infections that may lead to hospitalization or death.
Enbrel already has a warning - but not a "black box" warning - about malignancy risk.
By Miranda Hitti
Reviewed by Louise Chang
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