Company expects to get back to the agency in January 2009.
The FDA requires additional information from Centocor to approve ustekinumab for the treatment of chronic moderate-to-severe plaque psoriasis. The agency does not need nonclinical or clinical studies but asks for a risk evaluation and mitigation strategy (REMS).
“We are confident that we can expeditiously address the questions set forth in the Complete Response letter,” states Jerome A. Boscia, M.D., senior vp, clinical R&D. “We anticipate responding to the FDA in January 2009.”
The REMS is needed to ensure that benefits of an investigational or marketed treatment outweigh the risks. The ustekinumab REMS has to contain a medication guide and communication plan but does not require restricted distribution.
The BLA for ustekinumab was filed in late 2007 and seeks approval to market ustekinumab as a subcutaneous biologic therapy for adult patients. Ustekinumab is a human mAb that targets interleukin-12 and interleukin-23. These naturally occurring proteins are important in the body’s regulation of immune responses and are also believed to play a role in inflammatory disorders, including psoriasis.
On December 12, 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.