Janssen Biotech received a complete response letter from the FDA for its Plivensia (sirukumab) treatment for rheumatoid arthritis. The agency said additional clinical data are needed to further evaluate safety. Janssen said it is reviewing the details of the letter and plans to seek a follow-discussion with the FDA.
In August, an FDA advisory committee voted 12-to-1 against recommending approval, citing safety concerns. Two Phase III trials saw higher rates of deaths and malignancies compared to placebo, plus more cardiovascular-related adverse events in patients receiving a 50 mg dose compared to 100 mg.
Janssen’s BLA, filed Sept. 23, 2016, included data from a global Phase III program including five studies and approximately 3,100 patients, including those who continued to have active disease despite previous drug and biologic treatment.