FDA accepts Sanofi/Regeneron application for RA drug
- The FDA accepted the application by Sanofi and Regeneron for their rheumatoid arthritis med sarilumab, promising a final decision by October 30.
- Sarilumab is an antibody which reduces inflammation through IL-6 receptor inhibition. It is intended to treat inflammation in patients with rheumatoid arthritis (RA).
- Sanofi/Regeneron's application is supported by seven phase 3 clinical trials, across which sarilumab outperformed a placebo in addressing the symptoms of RA. The total clinical trial patient population exceeds 2,500.
According to the CDC, roughly 1.5 million adults in the U.S. have rheumatoid arthritis (RA) and the demand for additional treatment options is very strong. Additionally, many patients cannot tolerate anti-tumor necrosis factor (TNF) antibodies, such as the leading treatment Humira.
The partnership between Regeneron and Sanofi did well in 2015. Their PCSK9 inhibitor Praluent (alirocumab) for hypercholesterolemia was approved last January and performed solidly in its first year on the market. Assuming sarilumab is approved on October 30 (or before), the team will be two for two.
In addition, the Sanofi-Regeneron development team will continue to work on the development of dupilumab for treatment of various allergic diseases, including asthma and atopic dermatitis.