FDA issues letter to J&J subsidiary regarding ustekinumab psoriasis treatment

HORSHAM, Pa. The Food and Drug Administration has issued a complete response letter to a Johnson & Johnson subsidiary for a biologic to treat psoriasis.

Centocor announced Friday the issuing of the letter for its approval application for ustekinumab, which it filed with the FDA in late 2007.

The letter requests additional information, including a proposal by Centocor for a risk evaluation and mitigation strategy, which the FDA requires to ensure that benefits of an investigational or marketed treatment outweigh the risks. The REMS for ustekinumab must include a medication guide and communication plan, Centocor said.

“We are confident that we can expeditiously address the questions set forth in the compete response letter,” Centocor senior vice president for clinical research and development Jerome Boscia said. “We anticipate responding to the FDA in January 2009 and remain focused on bringing ustekinumab to market and ultimately to appropriate patients living with psoriasis and in need of treatment.”

The FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee unanimously recommended ustekinumab for approval in June, the company said.