FDA Extends Review Timeline for STELARA™ (Ustekinumab) Biologic License Application by Three Months
Horsham, PA .— Centocor Ortho Biotech Inc. announced today that the U.S. Food and Drug Administration (FDA) has extended by three months the review timeline for the Biologic License Application (BLA) for STELARA™ (ustekinumab) to provide time for a full review of an amendment to the pending application. The application seeks approval to market STELARA for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.
The amendment, submitted within three months of the user fee goal date, pertains to testing results to establish the product’s shelf life. The FDA has requested no additional clinical trials for STELARA. The U.S. BLA extension does not affect the approval or marketing of STELARA in Europe or Canada, nor does it apply to pending applications in other markets.
“We remain focused on collaborating with the FDA and providing the necessary information to support the review and approval of STELARA for the treatment of adults with moderate to severe plaque psoriasis,” said Jay P. Siegel, M.D., Chief Biotechnology Officer.
The FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) unanimously recommended STELARA for approval in June 2008. In December 2008, Centocor Ortho Biotech announced the receipt of a Complete Response letter for STELARA from the FDA requesting additional information, including a proposal for a Risk Evaluation and Mitigation Strategy (REMS), to which Centocor Ortho Biotech responded in January 2009. FDA’s review of the proposed REMS for STELARA and the proposed product labeling is ongoing.
Psoriasis is a chronic, immune-mediated disease that 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 Americans and nearly 3 percent of the world’s population are living with psoriasis and nearly one-quarter of those people have cases that are considered moderate to severe.
STELARA 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.
STELARA is approved in Canada for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for phototherapy or systemic therapy. In Europe, STELARA is approved for the treatment of moderate to severe plaque psoriasis in adults who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate and PUVA (psoralen plus ultraviolet A light).
Centocor discovered STELARA 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.
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