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Despite Enbrel Risks, FDA Panel Recommends it for Psoriasis in Children

Jun 19, 2008 | Parker Waichman Alonso LLP

A Food & Drug Administration (FDA) advisory panel has recommended that the agency approve Enbrel to treat moderate-to-severe psoriasis in children, despite concerns that the drug has been linked to cancer and serious infections, including tuberculosis.  Enbrel is already approved to treat psoriasis and rheumatoid arthritis in adults and juvenile arthritis in children.

Enbrel is made from a type of protein called a tumor necrosis factor (TNF) blocker that blocks the action of a substance made by the body’s immune system called TNF. People with an immune disease, such as rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and psoriasis, have too much TNF in their bodies. The FDA first approved Enbrel in 2000 for treating rheumatoid arthritis, and its approved uses where expanded several times to include psoriasis and other conditions.

In April, the FDA requested a new black box warning for the Enbrel label stating that the drug has been associated with serious infections, including tuberculosis in some patients. The new Enbrel black box warning was prompted by global studies of over 20,000 patients taking Enbrel, where tuberculosis was observed in about 200 people.

Earlier this week, the FDA said it would seek a stronger label on the drug to include warnings that its use could lead to children's deaths as well as moderate-to-severe infections.  Reports submitted to the agency linked Enbrel to infections that sometimes led to hospitalization and death. Of the 14 deaths recorded by the FDA, more than half were in children taking Enbrel for arthritis, while the others were among children taking the drug for unapproved uses.  The FDA scientists also recommended that stronger warnings about the possibly-fatal infections be added to Enbrel’s label.

The FDA is also reviewing Enbrel and other TNF blockers over a possible link to cancer.  The FDA is investigating about 30 reports of leukemia, lymphoma and other cancers in children and young adults submitted between 1998, after the approval of the first TNF blocker, through April of this year. Approximately half of the reports were lymphomas, cancer of the immune system cells, that were both Hodgkin’s and non-Hodgkin’s based.

Ultimately, the FDA advisory panel voted 7-5 with one abstention to recommend expanding Enbrel's approval.  The panel of outside medical experts said that Enbrel appears effective in treating psoriasis in children, but it expressed concern about whether the medicine will increase risks of malignancy and serious infections such as tuberculosis. Some panel members expressed concern about giving a drug with unknown side effects to children with only moderate psoriasis.  However, they did not recommend that Enbrel be approved only to treat severe psoriasis, saying that might limit whether insurance companies will cover the drug's costs.

The FDA is not bound to follow the recommendations of advisory panels, but the agency usually does so.