A potential treatment for moderate-to-severe rheumatoid arthritis, sirukumab, is under consideration by the U.S. Food and Drug Administration for approval, with the application supported by results from five Phase 3 clinical trials.
Johnson & Johnson (J&J) one of the companies developing sirukumab — through its subsidiary Janssen, working with GlaxoSmithKline — said in a recent business review statement that it anticipates approval soon, and, if so, expects to launch the treatment later this year in the United States. It is aimed at RA patients who have had an inadequate response to previous therapy regimens.
Sirukumab is a monoclonal antibody that specifically targets a protein called interleukin-6, or IL-6. This is a protein normally involved in inflammatory processes, but it is known to play a crucial role in the development of RA. Sirukumab has not yet been approved for RA or any medical condition in the United States or elsewhere.
An application for marketing approval was also filed with European Medicines Agency (EMA) in September 2016, about the same time the a Biologics License Application was submitted to the FDA.
Results of the Phase 3 SIRROUND Clinical Program, comprising five trials — SIRROUND-D, SIRROUND-T, SIRROUND-H, SIRROUND-M [in Japan], and SIRROUND-LTE — and involving more than 3,000 patients support the regulatory requests. The program assessed the safety and efficacy of subcutaneously administered sirukumab in treating RA.
Two treatment regimens were tested (only SIRROUND-LTE is ongoing, and expects to end in August 2020). Participants either received sirukumab 50 mg every four weeks or 100 mg every two weeks. Doses were administrated in combination with standard disease-modifying anti-rheumatic drugs (DMARDs) or as monotherapy.
“We are committed to deepening our understanding of rheumatoid arthritis with the goal of applying new scientific learnings to advance treatments like sirukumab for people living with this inflammatory rheumatologic disease,” Newman Yeilding, MD, head of immunology development at Janssen Research & Development, said in a press release.
At a meeting with industry analysts, J&J and Janssen also announced plans to launch or file for regulatory approval for more than 10 products in five core therapeutic areas between 2017 and 2021: immunology, infectious diseases and vaccines, neuroscience, cardiovascular and metabolism, and oncology.