Biogen, Inc., world's oldest independent biotechnology company, announced that the U.S. Food and Drug Administration (FDA) has approved Amevive (alefacept) for the treatment of adult patients with moderate-to-severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy.
Psoriasis is an autoimmune skin disease in which skin cells multiply 10 times faster than the normal rate. The excess cells pile up on the skin's surface, forming red, raised, scaly plaques that can be painful and disfiguring. Psoriasis affects about 80 million people worldwide and 4.5 million U.S. adults. Approximately 1.5 million U.S. psoriasis patients suffer from moderate-to-severe disease. According to a survey conducted by the National Psoriasis Foundation (NPF), one-third of these patients reported they were dissatisfied with current therapies.
Kenneth Gordon, M.D., Department of Dermatology, Northwestern University, and Amevive clinical investigator, said, "Amevive is unique because it seems to have a long-lasting effect. In our clinical trials, patients took the medication for 12 weeks and then stopped treatment for several months. During this time off treatment, many of our patients had prolonged remission of their disease. A number of my patients have told me that Amevive has made a real difference in their lives, giving them more confidence and allowing them to enjoy their favorite activities again."
James C. Mullen, Biogen's chairman and chief executive officer, said, The availability of Amevive is important because it offers a unique treatment option with the potential to provide patients with months free from both psoriasis and its treatment. For the last 15 years, Biogen has committed itself to the research and development of Amevive. We are proud to offer new hope for people with moderate-to-severe psoriasis."
Gail M. Zimmerman, president and CEO of the National Psoriasis Foundation said, "Many people in the public mistakenly think that psoriasis is a mild disease, a dandruff problem. It is far from that for many people. It can be emotionally and physically debilitating. Amevive represents a new class of drugs that probably represents one of the biggest advances for psoriasis in 20 years. This is exciting news for people with psoriasis."
Amevive must be administered under the supervision of a physician. Amevive induces dose-dependent reductions in CD4+ and CD8+ T-lymphocytecounts. CD4+ T-lymphocyte counts should be monitored weekly during the 12-week dosing period and used to guide dosing. Amevive is an immunosuppressive agent and could increase the risk of malignancies or infections. Adverse events commonly observed in the first course of placebo-controlled clinical trials with at least 2 per cent or higher incidence in patients treated with Amevive compared to those treated with placebo were: pharyngitis, dizziness, increased cough, nausea, pruritus, myalgia, chills, injection site pain, injection site inflammation and accidental injury.
People with mild psoriasis can often control their disease with topical agents, but more than one million patients with moderate-to-severe psoriasis worldwide require ultraviolet or systemic therapies. Amevive is a systemic therapy that works by helping to rebalance the overactive cells in the immune system that cause psoriasis. These cells, called T cells are the "messengers" of disease in psoriasis and other autoimmune disorders. Amevive is designed to reduce the number of these disease-causing cells. As measured in the Phase III clinical trials, PASI score improvement correlated with a reduction in T cells, confirming the importance of targeting them to control the disease.
More than 1,000 patients at 100 sites in the United States, Europe and Canada were enrolled in the Phase III clinical trials, which were conducted as double-blind, placebo-controlled studies. Patients in the trials were aged 16-84 years with chronic plaque psoriasis that covered at least 10 per cent of their total body surface area.