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Janssen receives complete response letter from FDA about sirukumab BLA for rheumatoid arthritis
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Janssen Biotech Inc. announced it received a complete response letter from the FDA for the biologics license application seeking approval of sirukumab for the treatment of moderately to severely active rheumatoid arthritis, according to a press release. The letter requested additional clinical data to evaluate the safety of the treatment.
“We are disappointed by this development as we feel the data accumulated to date support the efficacy and safety of sirukumab in the treatment of moderately to severely active rheumatoid arthritis,” Newman Yeilding, MD, head of immunology development at Janssen Research & Development LLC, said in the release. “We believe sirukumab represents an important therapeutic option for patients living with rheumatoid arthritis, especially for those individuals who cycle through multiple treatments and continue to struggle to find an effective option for a potentially disabling disease. 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 U.S. approval.”
The FDA Arthritis Advisory Committee did not recommend approval of sirukumab for treatment of rheumatoid arthritis (RA) on Aug. 2, 2017. The biologics license application for sirukumab was filed on Sept. 23, 2016 and included data from a phase 3 clinical development program that included five studies with about 3,100 patients with RA.
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