Genentech, Inc., and Xoma, Ltd., have announced the approval of efalizumab (Raptiva™) by the U.S. Food and Drug Administration (FDA) for the treatment of chronic, moderate-to-severe plaque psoriasis in adults age 18 or older who are candidates for systemic therapy or phototherapy. This is the first biological agent that is designed to provide continuous control of the condition and that can be self-injected subcutaneously at home by patients once a week.
Psoriasis occurs when new skin cell growth rapidly accelerates, resulting in thick, red, scaly, inflamed patches on the skin surface. Plaque psoriasis, the most common form of the disease, is characterized by inflamed patches of skin (lesions) topped with silvery-white scales. Although several medications do help to control the symptoms of psoriasis, no cure is available.
Raptiva™ is a humanized therapeutic antibody that selectively and reversibly blocks the activation, reactivation, and trafficking of T cells that lead to the development of psoriasis symptoms. Rap-tiva™ has demonstrated a rapid onset of action in reducing psoriasis-associated symptoms in some patients within four weeks of initiating treatment.
Adverse events included headache, infection (mostly upper respiratory), chills, nausea, pain, myalgia (muscle pain), flu syndrome, fever, back pain, and acne. Fewer than 1% of patients discontinued treatment because of acute adverse events.
Raptiva™ is an immunosuppressive agent and has the potential to increase the risk of infection and to reactivate latent, chronic infections. Many immuno-suppressive agents have the potential to increase the risk of malignancy. The role of Raptiva™ in the development of malignancies is not known.