FDA extends review of BLA for ustekinumab

The US Food and Drug Administration has extended the review timeline for the Biologic License Application for US firm Centocor's ustekinumab, a subcutaneous biologic therapy, by three months to December. The application, filed by Centocor late in 2007, seeks approval to market ustekinumab for the treatment of adult patients with chronic moderate-to-severe plaque psoriasis.

The FDA extended the review period to provide additional time for review of amendments to the application provided by Centocor within the last three months. The FDA has requested no additional clinical trials.

On June 17, the FDA's Dermatologic and Ophthalmic Drugs Advisory Committee unanimously recommended ustekinumab for approval. The 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. Ustekinumab is also under review by the European Medicines Agency (EMEA), Centocor, a subsidiary of US health care giant Johnson & Johnson, points out.