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FDA extends review on J&J psoriasis drug candidate
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NEW YORK - Johnson & Johnson said late Tuesday that regulators have extended a review period on a drug candidate intended to treat psoriasis.
The Food and Drug Administration will take up to three more months to review the application for Stelara, although it did not ask for any new clinical tests. The injection is designed to treat moderate to severe plaque psoriasis. It was developed by Johnson & Johnson's Centocor Ortho Biotech division.
The FDA previously delayed a ruling on Stelara in December, asking for more information on the company's risk evaluation and mitigation strategy. Centocor sent its response in January. Stelara has been approved in the European Union and Canada.
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