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 Enbrelmarketing 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.
