Seven panel members from the advisory committee voted in favor of recommending approval while five voted against and one abstained. The panel said the drug appears effective but expressed concerns about increased risks of malignancy and serious infections like tuberculosis.
Although the FDA generally follows the advice of its panels, which are composed of outside medical experts, it is not mandatory for it to do so.
Manufactured by Thousand Oaks, Calif.-based company Amgen Inc., Enbrel is already approved to treat rheumatoid arthritis in adults and children, and psoriasis in adults. Common symptoms of the disease are dry, cracked and red-patched skin.
The panels' concerns were similar to those it raised Tuesday about ustekinumab, a proposed drug by Johnson & Johnson (JNJ) to treat moderate-to-severe psoriasis in adults. The panel unanimously recommended approval for J&J's proposed drug.
Last Friday, the federal agency warned 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 highlighted the need to evaluate additional safety data before deciding whether the drug increased the likelihood of cancer.
