Genentech Inc and Xoma Ltd. have submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for Raptiva (Efalizumab), a recombinant humanized monoclonal antibody under evaluation for the treatment of moderate-to-severe plaque psoriasis.
Based on the data from our Phase III studies and the more than 2,100 patients in our safety database, we believe that Raptiva has the potential to become an important new therapy for patients with moderate-to-severe psoriasis," said Susan D. Hellmann, Genentech's executive vice president, Development and Product Operations, and chief medical officer. "Psoriasis, a disease with a significant unmet medical need, affects more than 4.5 million people in the United States."
"The filing of the BLA represents a significant milestone for Xoma and is the successful result of the strong, collaborative efforts of Genentech and Xoma employees," said Jack Castello, Xoma's president and chief executive officer. "Both companies have worked especially hard over the past year to bring Raptiva to this stage, and we are pleased to have met the year end filing target we established in early May. I believe that if approved, Raptiva will make a significant, positive impact on the treatment of psoriasis."