- Sanofi and partner Regeneron revealed Friday that rheumatoid arthritis drug sarilumab received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration, ahead of sarilumab's user fee action date of Oct. 30.
- The CRL was due to manufacturing issues at the Sanofi Le Trait facility in France where the drug is filled and finished.
- Sanofi said in a statement that it has given the FDA a "comprehensive corrective action plan" and that it is putting those plans into place. The Biologics License Application (BLA) cannot be approved until the manufacturing issues are corrected.
"I should note that manufacturing deficiencies, not specifically related to sarilumab, were cited during a routine FDA inspection of current good manufacturing practice at one of our fill and finish plants where sarilumab syringes are filled. We have worked diligently with the FDA to respond to and address these deficiencies," said Sanofi CEO Olivier Brandicourt during the company's third quarter earnings call Friday morning.
The active pharmaceutical ingredients of sarilumab are made in Regeneron's facility in Rensellear, NY and then turned over to Sanofi's French plant for processing and filling of the syringes.
It's unclear how long the issues will take to resolve themselves. Yet, Brandicourt added during the call that the manufacturing issues would not affect supply of currently marketed products or other product under review, including the atopic dermatitis drug dupilumab, which has a March 29 approvable date.
Sarilumab isn't expected to be a major driver of revenue for either Sanofi or Regeneron. Analysts estimate the drug could bring in $1 billion in sales in 2025, which would be split between the two companies.
While the drug has shown superiority to Humira (adalimumab) in a head-to-head study, it is entering a crowded market. The RA market is already dominated by blockbuster TNF inhibitors and many of those are going off patent and have biosimilar versions entering the market as well.
There are also other IL-6 inhibitors on the market or in development, including Roche's Actemra (tocilizumab) and GlaxoSmithKline's sirukumab, which was submitted for FDA approval earlier this fall.