The US Food and Drug Administration (FDA) has extended the review timeline for Centocor Ortho Biotech’s biologic licence application (BLA) for Stelara (ustekinumab).
The application was filed for approval to market Stelara, for the treatment of adult patients with moderate-to-severe plaque psoriasis and who are candidates for phototherapy or systemic therapy.
Centocor Ortho Biotech chief biotechnology officer Jay P Siegel said that the company remain focused on collaborating with the FDA and providing the necessary information to support the review and approval of Stelara.
The amendment contains testing results to establish self-life of the product. FDA has requested no additional clinical trial for Stelara.
Earlier in June 2008, FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) unanimously recommended Stelara for approval. In December 2008, Centocor Ortho Biotech received complete response letter from the FDA requesting additional information, including a proposal for a risk evaluation and mitigation strategy.