FDA review for Sanofi and Regeneron’s biologic arthritis drug
pharmafile | January 8, 2016 | News story | Medical Communications, Sales and Marketing |Â Â FDA, Regeneron, Sanofi, biologics, rheumatoid arthritis, sarilumabÂ
The FDA has accepted for review a Biologics License Application (BLA) from Sanofi and Regeneron for the rheumatoid arthritis treatment sarilumab, with a decision due by 30 October 2016.
Sarilumab is a human monoclonal antibody directed against the IL-6 receptor that is intended for the treatment of patients with active, moderate-to-severe rheumatoid arthritis (RA). IL-6 is the most abundant cytokine in the blood and joint fluid of patients with RA, and its levels correlate with both disease activity and joint damage.
The BLA for sarilumab contains data from approximately 2,500 adults with active, moderate-to-severe RA who had an inadequate response to previous treatment regimens, including seven studies from the global SARIL-RA Phase III program.
In the SARIL-RA-TARGET study, from which results were presented last May, 546 RA patients who couldn’t take or who had not improved after taking TNF-alpha inhibitors saw improved symptoms after 24 weeks and improved patient’s physical function after 12 weeks.
After 24 weeks 61% of people who took a 200 milligram dose of sarilumab showed a significant improvement in their symptoms, compared to 56% of people in the 150 mg dose group and 34% in the placebo group.
If approved, the treatment will go up against existing RA therapies including AbbVie’s Humira (adalimumab), the world’s top-selling drug. Eli Lilly is another contender in the market. In November, the company announced its investigational therapy baricitinib outperformed Humira in a late stage study.
Sanofi partnered with Regeneron in 2007 in a discovery research agreement under which both companies identify targets, before Regeneron generates related antibodies and conducts pre-clinical development until the regulatory filing.
Joel Levy
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