FDA issues complete response to biologics license application for ustekinumab

Centocor, Inc., has announced that the U.S. Food and Drug Administration (FDA) issued a Complete Response letter for its Biologics License Application (BLA) for ustekinumab.

The application, filed by Centocor in late 2007, seeks approval to market ustekinumab as a subcutaneous biologic therapy for the treatment of adult patients with chronic moderate to severe plaque psoriasis.

The Complete Response letter requests additional information, including a proposal by Centocor for a Risk Evaluation and Mitigation Strategy (REMS). FDA requires REMS to ensure that benefits of an investigational or marketed treatment outweigh the risks. The ustekinumab REMS must contain a Medication Guide and communication plan. It does not require restricted distribution. The FDA has not requested any new non-clinical or clinical studies evaluating the efficacy or safety of ustekinumab prior to approval.

"We are confident that we can expeditiously address the questions set forth in the Complete Response letter," said Jerome A. Boscia, M.D., senior vice president, Clinical R&D, Centocor, Inc. "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."

On June 17, 2008, the FDA's Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) unanimously recommended ustekinumab for approval. DODAC is convened on request of the FDA to review and evaluate safety and efficacy data of human drug products for use in the treatment of dermatologic and ophthalmologic conditions. The committee provides non-binding recommendations based on its evaluation; however, the FDA makes the final decision on approval of the drug.

Psoriasis is a chronic, immune-mediated disease, which results from the overproduction of skin cells, resulting in their accumulation on the surface of the skin, which causes red, scaly plaques that may itch and bleed. It is estimated that approximately 7.5 million people in the United States and 10 million Europeans are living with psoriasis and nearly one-quarter of those people have cases that are considered moderate to severe.

Ustekinumab is a new, human monoclonal antibody in Phase 3 development by Centocor, Inc. for the treatment of moderate to severe plaque psoriasis, and is being investigated as an infrequently administered subcutaneous injection. Ustekinumab is a new, human monoclonal antibody with a novel mechanism of action that targets the cytokines interleukin-12 (IL-12) and interleukin-23 (IL-23), naturally occurring proteins that are important in the body's regulation of immune responses and that are also believed to play a role in inflammatory disorders, including psoriasis.

On November 21, 2008, the European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for ustekinumab for the treatment of moderate to severe plaque psoriasis in adult patients who failed to respond to other systemic therapies.

On December 12, 2008, the Canadian Health Authority approved the use of ustekinumab for the treatment of chronic moderate to severe plaque psoriasis in adult patients who are candidates for phototherapy or systemic therapy.

Centocor discovered ustekinumab and has exclusive marketing rights to the product in the United States. Janssen-Cilag companies have exclusive marketing rights in all countries outside of the United States.

http://www.jnj.com/