FDA panel backs ustekinumab for psoriasis

The FDA's Dermatologic and Ophthalmic Drugs Advisory Committee on Tuesday voted 11-0 to recommend approval of a BLA for ustekinumab from Johnson & Johnson (NYSE:JNJ) to treat moderate-to-severe psoriasis. However, the committee voted 11-0 that the company's current risk assessment proposals were not adequate and voted 7-4 in favor of prescriber-administration vs. self-administration to allow for closer monitoring of both efficacy and adverse events. The panel, which cited preclinical cancer signals in rodents, felt there was not adequate safety data available to assess long-term risks of ustekinumab and recommended that a stringent mandatory registry be implemented to allow collection of safety data. ...