Sanofi CEO Olivier Brandicourt believes the French drugmaker has fixed the issues at a fill/finish plant in France that led it and partner Regeneron to get a complete response letter for experimental rheumatoid arthritis drug sarilumab and that they should be back on track with their application this quarter.
Speaking at the JPMorgan Healthcare Conference Tuesday, Brandicourt told attendees that after a review of Sanofi’s responses and proposed corrective actions for the the plant in Le Trait, “the FDA has classified the Le Trait fill and finish facility as acceptable,” according to a webcast of the CEO’s presentation.
He said the companies expect the FDA to return for a reinspection this quarter and assuming the plant passes the review, they believe they are "on track" to resubmit the BLA for the IL-6 inhibitor FDA consideration yet in Q1.
Then Sanofi’s reading on the FDA on this issue so far has not been completely on target. Just hours before receiving the complete response letter (CRL) for the drug last November, Brandicourt was intimating to analysts in an earnings call that the deficiencies were not that significant. He pointed out they were not specifically about sarilumab.
But according to the highly redacted Form 483 the FDA found lots to note, including retained samples from some lots that contained “visual particulates” that the agency said Sanofi had released without determining a root cause for the contamination. The document also notes “failure of two consecutive media fills on a line where Chaetomium subaffine was discovered.
In a note to investors, Barclays analysts said that while they saw Brandicourt’s update as generally positive, they needed “further confirmation that all has been resolved in the facility.” They also said their expectations for sarilumab “are muted as it is entering an already crowded RA market.”
The drug has been projected by EvaluatePharma to reach 2020 sales of $1.8 billion and in a head-to-head with AbbVie’s Humira, the best-selling drug in the world, it performed well. But sarilumab lands as biosimilars are preparing to enter the market. The FDA last fall approved Amgen’s Amjevita but AbbVie promptly sued over the competitor leaving its entry into the market uncertain for now.