Janssen announced that Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the Biologics License Application (BLA) of sirukumab in the treatment of moderately to severely active rheumatoid arthritis (RA).
The CRL indicated a request for additional clinical data in order to evaluate the safety of sirukumab in the treatment of RA. The sirukumab BLA was filed in September 2016 and included data from the Phase 3 clinical development program comprised of 5 studies in approximately 3,100 RA patients.
Sirukumab is a fully human monoclonal IgG1 kappa antibody that selectively inhibits the circulating interleukin (IL)-6. IL-6 is thought to be involved in autoimmune conditions like RA.
The FDA’s Arthritis Advisory Committee did not recommend approval of sirukumab for RA when they convened in August 2017. Janssen plan to have a follow-up discussion with the Agency to gain a better understanding of the requirements for approval.
Janssen receives complete response letter from US FDA for sirukumab biologics license application [press release]. Horsham, PA: Janssen. http://www.janssen.com/janssen-receives-complete-response-letter-us-fda-sirukumab-biologics-license-application. Published September 22, 2017. Accessed October 6, 2017.
This article originally appeared on MPR