Johnson & Johnson subsidiary, Janssen Biotech, announced that its biologics license application for experimental arthritis therapy, sirukumab, was rejected by the FDA.
FDA's complete response letter said that additional clinical data are needed to further evaluate the safety of the new drug candidate.
The rejection should not come as a surprise to J&J, after an FDA panel voted 12-1 against the approval of the drug in August, citing safety concerns. A week prior to the panel rejection, GSK announced that it would end its collaboration with J&J on the experimental drug.
Sirukumab is currently still under review by health authorities in Europe and Japan as a subcutaneous therapy for the treatment of adult patients with moderately to severely active RA.
Read the press release