Wyeth’s Enbrel for treatment of Psoriasis

On July 30, 2004 Wyeth reported that a European Commission panel had recommended that regulators approve Enbrel as a treatment for psoriasis after other treatments were found inadequate or inappropriate. The Committee for Medicinal Products for Human Use will report its findings to the European Commission for endorsement before Enbrel can receive marketing approval. Wyeth is responsible for marketing Enbrel outside North America and co-promotes the drug with Amgen Inc. in North America. The company is recommending the approval of Enbrel, also a treatment for rheumatoid arthritis, for the treatment of adults with moderate to severe psoriasis when phototherapy or systemic treatments have been inadequate or are inappropriate. According to Wyeth, a study of more than 1,200 plaque psoriasis patients showed that the drug lead to a rapid and significant clearing of skin lesions and improvement in quality-of-life scores compared with placebo. This most recent approval adds to Enbrel’s previously FDA approved indications of Psoriasis, Rheumatoid Arthritis, Juvenile Rheumatoid Arthritis, Ankylosing Spondylitis, and Psoriatic Arthritis.

Enbrel is a protein that is thought to exert its action through the binding and subsequent inactivation of a naturally produced cytokine known as Tumor Necrosis Factor (TNF). TNF is produced by the body’s immune system. In patients with psoriasis and other autoimmune diseases, certain immune cells increase production of TNF. This increased TNF activity is thought to be critical in mediating the overactive immune response that causes the tissue damage that is a hallmark of psoriasis and rheumatoid arthritis. Amgen has indicated that approximately 234,000 patients have already been treated with Enbrel worldwide. Amgen reports total sales of Enbrel for 2003 in the 1.3 billion dollar range.

The true incidence of psoriasis in the United States is difficult to determine. Estimates of prevalence suggest that approximately 4.5 million people are affected by psoriasis with approximately one third of these suffering from the ‘plaque’ type of the disease. Psoriasis is characterized by the development of red, itchy skin plaques that are often painful and disfiguring.

Enbrel satisfies all BioHorizon criteria for High Impact Technologies: it is an innovative therapy, it has diffused rapidly, it has demonstrated efficacy in clinical trials, and with this most recent approval, it is indicated for more prevalent conditions. In light of the psoriasis indication, clients should begin or revisit assessment activities at this time.

Technology Details
Target Disease / Indication: Psoriasis
Technology Classification: Drug
Body System: Dermatologic
Program Area: Medicine/Infectious Disease
Regulatory Status: Phase III
BioHorizon Impact Score: 63/100-Moderate/High Impact