FDA panel backs expanding Enbrel to treat psoriasis in kids

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FDA panel backs expanding Enbrel to treat psoriasis in kids

http://www.pharmatimes.com/WorldNews/article.aspx?id=13739

19 June 2008

Amgen has been lifted by the news that regulatory panel members in the USA

have recommended expanding the use of the firm's blockbuster Enbrel to treat

psoriasis in children.

The Dermatologic and Ophthalmic Drugs Advisory Committee of the US Food and

Drug Administration voted 8-5 to back Enbrel (etanercept) for the treatment

of children and adolescents with chronic moderate-to-severe plaque

psoriasis. If the FDA backs the panel's recommendation, and it usually does,

Enbrel, a tumour necrosis factor blocker, would be the first approved

treatment for children with the painful skin disease. The drug is already

approved to treat psoriasis and rheumatoid arthritis in adults, and juvenile

arthritis in children.

However the panel expressed some reservations about the treatment, saying

that its use should be confined to only the most serious cases, due to

potentially dangerous side effects, including cancer. Earlier this month,

the FDA said it was investigating approximately 30 reports of cancer in

children and young adults who were treated with TNF blockers.

Amgen and Enbrel marketing partner Wyeth were positive about the DODAC's

review and said that the committee had adopted a position " that is

consistent with both companies' perspective that the benefits outweigh the

risks in the population studied and that use should be reserved for

appropriate patients " .

The firms added that an expanded indication for Enbrel would address the

unmet medical need " for an approved and well-studied therapy in this small,

under-served paediatric psoriasis patient population " . Amgen is also

proposing a risk management programme " to foster appropriate use " of the

drug.