Amgen set for Dodac review

Amgen has been invited to participate in a meeting of the Dermatologic and Ophthalmic Drugs Advisory Committee (Dodac) to review data relating to its supplemental Biologic License Application (sBLA) for Enbrel, the company has announced.

The firm was asked to take part in the review by the Food and Drug Administration, it added.

Enbrel is a treatment for paediatric patients with chronic to moderate severe plaque psoriasis, who are either inadequately treated by topical therapies or have already received systemic therapy or phototherapy.

Amgen said data included in the sBLA showed that children and adolescents suffering from the condition who were treated with Enbrel showed “significant improvements” compared to those treated with placebo.

The company’s executive vice-president of research and development, Roger M Perlmutter, commented that if Dodac approves its sBLA, Enbrel would become the first biologic or systemic therapy to treat psoriasis in children and teenagers.

“We look forward to the opportunity to discuss the benefits and risks of Enbrel treatment for these patients, who have few approved options to help manage their disease,” he added.

Amgen works to discover, develop and deliver new human therapies. The company employs around 17,500 people worldwide and in 2007, its product sales topped $14.8 billion (7.45 billion pounds).