Manufacturing

FDA flashes red light on Sanofi manufacturing infraction, threatening a looming blockbuster decision

The French pharma giant Sanofi has a lot riding on the approval of sarilumab. Partnered with Regeneron, peak sales estimates top $1 billion for this drug, which beat megablockbuster Humira in a head-to-head study on rheumatoid arthritis. Only now Sanofi may not be able to keep up its end of the deal.

In a note included in its Q3 update, Sanofi says that the FDA has cited their manufacturing operations for certain unspecified deficiencies. And that may derail the looming approval they were looking for. Here’s the note:

Manufacturing deficiencies have been raised by the FDA during a routine Current Good Manufacturing Practice (CGMP) inspection of a Sanofi manufacturing facility, which conducts “fill and finish” activities. Sanofi has provided comprehensive responses to the FDA for the cited deficiencies. Given that the CGMP status of this facility is still under review by the FDA, it is unclear whether this situation will impact the approval for sarilumab on its PDUFA date of October 30, 2016.

October 30 is a Sunday, meaning that the formal decision could be expected later today. For Sanofi, it’s a fresh reminder of just how much is riding on its relationship with Regeneron, which is also advancing dupilumab under their collaborative relationship. For Regeneron, it’s also a reminder of Sanofi’s often star-crossed attempt to advance new meds into the market.


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RAPS Regulatory Convergence 2017