Biogen to apply for approval of Amevive

Following Biogen reporting promising results from two Phase III clinicaltrials of Amevive (alefacept) earlier this month for the treatment of patients with moderate-to-severe plaque psoriasis (Marketletter June 18), the company will submit applications to the US Food and Drug Administration and the European Medicines Evaluation Agency for the approval of the product in this indication.

In both an intramuscular and an intravenous trial of Amevive in patients suffering from chronic plaque psoriasis, a disease for which there is no cure, covering at least 10% of their body, the drug met the primary efficacy endpoint, a 75% or greater improvement in the Psoriasis Area and Severity Index score two weeks after completion of a 12-week course of treatment. Additional analyses showed a 71% reduction in patients receiving two iv courses of Amevive therapy, a 50% or greater reduction in baseline PASI score, and 40% saw at least a 75% reduction.

Both trials also demonstrated that individuals receiving the drug achieved a significantly improved quality of life, as measured by the Dermatology Life Quality Index. Overall rates of adverse reaction in these trials were similar in both Amevive and placebo groups, the most common being accidental injury, headache, pruritis, infection, pharyngitis and rhinitis.