Sanofi, Regeneron set to resubmit sarilumab
- Sanofi and Regeneron Pharmaceuticals plan to resubmit an application for approval of Kevzara (sarilumab) to the Food and Drug Administration this quarter, getting back on track after a complete response letter from the regulator last October derailed the rheumatoid arthritis drug candidate.
- The FDA had initially rejected the application for Kevzara due to deficiencies found at Sanofi's fill and finish manufacturing plant in Le Trait, France. But the agency has now reclassified the facility as "acceptable" based on Sanofi's proposed corrective action plan.
- If all checks out in a pre-approval inspection, the team expects a resubmitted application will be reviewed within two months.
Manufacturing issues led to more complete response letters from the FDA last year than for any other year between 2010 and 2015, pushing several planned review cycles into 2017.
Sanofi and Regeneron were hit with one of those CRLs in October 2016, just ahead of the expected decision date for Kevzara. A routine GMP inspection had found manufacturing concerns at the Le Trait plant, setting back the arthritis drug and threatening to impact the duo's Dupixent (dupilumab) as well.
But Sanofi appears to have been able to remedy the shortcomings fairly quickly and the pharma/biotech team is confident of sending a biologics license application back to the FDA within the next seven weeks or so.
"We've made good progress since our last quarterly earnings call in remediating our fill-finish plant in Le Trait and subject to successful FDA inspection, we plan to resubmit our BLA for Kevzara in rheumatoid arthritis this quarter," said Olivier Brandicourt, CEO of Sanofi, on an earnings call this week.
Kevzara is a monoclonal antibody targeting the IL-6 receptor to treat rheumatoid arthritis. The drug won its first approval from Health Canada last month and the two companies have readied field teams in preparation of a U.S. launch.
The rheumatoid arthritis market is crowded, and Sanofi and Regeneron are working to expand the evidence base supporting Kevzara in order to compete. In the Phase 3 SARIL-RA-MONARCH study, Kevzara monotherapy was shown to be more effective at improving the signs and symptoms of the disease in adults with active rheumatoid arthritis compared to AbbVie's market-leading Humira (adalimumab).
Both companies are banking on Kevzara and Dupixent to accelerate growth and expand their immmunology portfolios.
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