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FDA Panel Recommends Enbrel for Pediatric Patients
Date:6/18/2008

But experts also express concern about psoriasis drug's possible risks for children; action follows agency warning that drug label needs strengthening

WEDNESDAY, June 18 (HealthDay News) -- A U.S. Food and Drug Administration advisory panel recommended Wednesday that the psoriasis drug Enbrel be approved for use in children who have moderate-to-severe forms of the skin disease.

The outside medical experts, in a 7-5 vote with one abstention, said the drug appears effective, but they did express concerns about whether it increases risks of malignancy and serious infections like tuberculosis, according to Dow Jones.

The panel's action follows an FDA announcement Monday that it wants a beefed up label on the drug, whether or not it gets expanded approval for children, to include warnings that its use could lead to children's deaths as well as moderate-to-severe infections. The drug, manufactured by Amgen, is already approved to treat rheumatoid arthritis in adults and children, and psoriasis in adults only.

The agency staff said Monday that a review of its database of adverse events showed there were cases of serious malignancies, infections and neurological problems tied to pediatric patients who took Enbrel (etanercept).

The advisory panel's concerns about Enbrel were similar to those raised Tuesday when it voted unanimously to recommend approval of ustekinumab, a proposed drug by Johnson & Johnson to treat psoriasis in adults, according to Dow Jones.

The FDA had warned last Friday, on its Web site, that while ustekinumab may be effective in treating moderate-to-severe psoriasis, it also may raise users' risk of cancer. The agency also said that it probably needed to evaluate additional safety data before deciding whether the drug increased the likelihood of cancer, the Wall Street Journal reported.

Although the FDA generally follows its experts' recommendations, it is not required to do so.

The panel reviews of both drugs follow an FDA safety review begun last month on the class of drugs known as tumor necrosis factor (TNF) blockers, which are widely prescribed to treat autoimmune disorders such as rheumatoid arthritis, juvenile rheumatoid arthritis, Crohn's disease and psoriasis.

Among the chief concerns being investigated are whether the drugs are associated with the development of cancer, especially lymphoma, in children and young adults being treated for rheumatoid arthritis or Crohn's disease.

The agency is investigating about 30 reports of cancer in this younger age group submitted between 1998, after the approval of the first TNF blocker, through April of this year. TNF blockers have also been linked to an increased risk of infection.

"I think it's a fair thing to say this is an area of ongoing concern that has not been resolved. It's not something new," Dr. Chaim Putterman, chief of the division of rheumatology at Montefiore Medical Center and Albert Einstein College of Medicine in New York City, said last month when the FDA review was announced. "[The drugs] were approved in adults, and more drugs are coming out, and everyone would prefer an indication in children, so the FDA has decided to clear it. It has always been a concern, and it's something that should be clarified."

Four TNF blockers are currently approved in the United States: Enbrel, Humira (adalimumab), Remicade (infliximab) and Cimzia (certolizumab).

The FDA review is focusing on the first three. All four are approved for multiple indications.

The drugs have clear benefits, experts said last month, and have revolutionized the treatment of some of these diseases.

"One of the reasons that these medications have such a market despite the concerns is that they are so remarkably effective," Putterman said. "There are not only subjective benefits but a tremendous amount of objective evidence, not only in inflammation and patient symptoms, but also in disease progression. These drugs have really addressed a previously unmet need."

Dr. Stephen Lindsey, head of rheumatology at Ochsner Health Service in Baton Rouge, La., said, "These drugs are probably the most important advance in the treatment of rheumatoid disorders in the last 20 to 30 years. They dramatically improve certain forms of crippling arthritis and almost stop them. Some people go from being in a wheelchair [to] jumping up and walking around."

He added: "They're being used earlier and earlier, because they're so good. I think the FDA is being cautious. I think it's smart. What are the risks of a child being crippled and non-functioning versus the risk of cancer? Maybe, in odd cases, we need to think more and not jump in with all four limbs."

More information

The U.S. Food and Drug Administration has more on TNF blockers.



SOURCES: Chaim Putterman, M.D., chief, division of rheumatology, Montefiore Medical Center and Albert Einstein College of Medicine, New York City; Stephen Lindsey, head, rheumatology, Ochsner Health Service, Baton Rouge, La.; Dow Jones; Wall Street Journal


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