Johnson & Johnson announced Friday that the FDA issued a complete response letter regarding its marketing application for Plivensia (sirukumab) as a potential treatment for moderately to severely active rheumatoid arthritis (RA). According to the company, the agency asked for additional clinical data to further evaluate the safety of the experimental anti-IL-6 monoclonal antibody in this indication.
The decision comes after an FDA advisory panel declined to support approval of Plivensia last month, voting 12-1 that the drug's benefits do not outweigh its risks. In documents released ahead of the panel meeting, FDA staff had cited evidence of increased overall mortality for the drug versus placebo, with common causes of death being major adverse cardiovascular events, infection and malignancy.
Newman Yeilding, head of immunology development at Johnson & Johnson's Janssen R&D unit, remarked "we are disappointed by this development as we feel the data accumulated to date support the efficacy and safety of [Plivensia] in the treatment of moderately to severely active RA." Yeilding added "we are reviewing the details of the complete response letter and plan to have a follow-up discussion with the agency to gain a full understanding of FDA requirements for US approval."
FirstWord reports in this therapy area - KOL Insight Rheumatoid Arthritis: Find out how KOLs expect the market to evolve, which pipeline treatments are most promising, and which clinical trials will shape treatment decisions. Learn more.
Johnson & Johnson noted that its submission was backed by data from Plivensia's Phase III clinical programme consisting of five studies and about 3100 patients with RA, including those who continued to have active disease despite prior use of disease-modifying anti-rheumatic drugs and biologic treatments. Positive results from the late-stage SIRROUND-D, SIRROUND-H and SIRROUND-T trials were released in 2015, while additional data from SIRROUND-D unveiled last year showed that the drug significantly slowed joint damage and improved RA symptoms, compared with placebo.
Johnson & Johnson previously identified Plivensia as one of more than 10 drugs with blockbuster potential that it intends to launch or submit for regulatory approval by 2021. The company will regain exclusive global rights to Plivensia in November following partner GlaxoSmithKline's recent decision to discontinue development of the drug as part of a broader strategic initiative. The therapy is currently under review in Europe and in Japan as a subcutaneous therapy for adults with moderately to severely active RA.
Meanwhile, Eli Lilly and partner Incyte announced last month that they hope to resubmit their FDA filing for the once-daily oral JAK inhibitor Olumiant (baricitinib) in moderate-to-severe RA before the end of January 2018. The companies had previously suggested that there would be at least an 18-month delay before they could resubmit the drug, which the FDA rejected in April.
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