Raptiva recommended by FDA advisory committee for the treatment of psoriasis

Journal of Drugs in Dermatology, Dec, 2003

The FD/Ks Dermatologic and Ophthalmic Drug Advisory Committee (DODAC) voted unanimously (11-0) to recommend that Raptiva[TM] (efalizumab) be approved for the treatment of moderate-to-severe plaque psoriasis in adults age 18 or older. Although the FDA is not bound by the recommendations of its advisory committees, it generally follows their advice.

Raptiva is a humanized anti-CD 11a monoclonal antibody that inhibits the binding of T-cells to other cell types. Binding of Raptiva to its targets inhibits several key steps in the pathogenesis of psoriasis. These processes include: (1) binding of T-cells through interactions with adhesion molecules on the endothelial cell surface; (2) trafficking of T-cells to the skin, and (3) activation of T-cells.

The DODAC recommendation came after evaluating the Phase III study. At week 12 of the randomized, double blind, placebo-controlled study, 27 percent (98/369) of the patients receiving Raptiva achieved PASI 75, and 59 percent (216/369) of patients achieved a 50 percent or greater PASI improvement (PASI 50). At 24 weeks of the open-label, extended treatment period following the first 12 weeks of treatment, 44 percent (161/369) of patients who had received at least one dose of Raptiva during the first 12 weeks achieved PASI 75 and 66 percent (245/369) of patients achieved PASI 50. Raptiva demonstrated rapid onset of action in the reduction of symptoms associated with psoriasis. The therapy was administered once weekly via subcutaneous injection.

Raptiva was well generally well-tolerated. Adverse events included headache, chills, pain, flu syndrome, fever, asthenia, nausea, myalgia (muscle pain), and pharyngitis.

Raptiva is being developed by Genentech and XOMA in the United States.