Wyeth Pharmaceuticals, a division of Wyeth, announced that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMEA), has voted to recommend approval for Enbrel (etanercept) for the treatment of adults with moderate to severe plaque psoriasis for whom phototherapy or conventional systemic treatments have been inadequate or are inappropriate. This positive opinion will be forwarded to the European Commission for endorsement before Enbrel can receive final Marketing Authorization, the release from Wyeth said.
"Enbrel would provide a needed and welcome new treatment option for people in Europe with moderate or severe psoriasis, a potentially disabling disease," says Dr. Joseph Camardo, senior vice president, Global Medical Affairs, Wyeth Pharmaceuticals.
The principal data supporting the efficacy and tolerability of Enbrel to treat psoriasis are from two randomized, double-blind, placebo-controlled studies that enrolled more than 1,200 adults with plaque psoriasis who were treated with continuous Enbrel therapy for 24 weeks. In both studies, patients who received Enbrel demonstrated a rapid and significant clearing of skin lesions and improvement in quality-of-life scores compared with placebo.
"When approved, Enbrel would become the first TNF-receptor therapy for the treatment of psoriasis in Europe; however, physicians and patients around the world have used Enbrel in 12 years of collective clinical experience for a variety of diseases," says Dr. Magnus Jaderberg, vice president of Global Medical Affairs and European Medical Director of Wyeth Pharmaceuticals.
"Enbrel has already been used in more than 250,000 patients worldwide across several indications, so the potential availability of Enbrel for the treatment of moderate to severe psoriasis can offer patients a new option with an established safety profile," he added.
The principal data supporting the efficacy and tolerability of Enbrel for the treatment of adults with chronic plaque psoriasis are from two phase 3 studies.
Enbrel was generally well tolerated in both studies. The types of adverse events were similar to those reported in previous clinical trials of Enbrel in other indications. The most common adverse events in the Enbrel group when compared to placebo were injection-site reactions and headaches. Upper respiratory tract infections were also common but occurred with the same frequency as in the placebo group.
Psoriasis is a chronic immune disorder characterized by red, scaly skin lesions, which can be itchy, painful, and unattractive. Psoriasis is believed to develop when certain immune cells become overactive and release proteins called cytokines.
Tumour necrosis factor (TNF) is a cytokine that helps regulate the body's immune response to infection and inflammation. In patients with psoriasis, higher than normal concentrations of TNF cause inflammation, which can lead to the overgrowth of skin cells and subsequent formation of psoriasis plaques. As a TNF-receptor therapy, Enbrel binds to TNF and renders it biologically inactive, which can result in a significant reduction in inflammation.
Wyeth Pharmaceuticals markets Enbrel outside North America. Enbrel was discovered by Immunex, now part of Amgen, and jointly developed with Wyeth Pharmaceuticals. The two companies co-promote Enbrel in North America.