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:
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