Regeneron, Sanofi win red-carpet treatment at the FDA for a blockbuster contender
This time, Regeneron and Sanofi didn’t have to buy a priority review voucher to try to speed up their regulatory timeline on a big drug. The FDA gave it to them for free on dupilumab, chopping four months off the review process and marking the PDUFA date on March 29.
The IL-4/IL-13 inhibitor is widely viewed as one of the potential blockbusters most likely to succeed in the market. For Regeneron, it’s a chance to continue to build on a sterling R&D rep. For Sanofi, which has made its collaborations with Regeneron a central feature of its R&D game plan, it’s a shot at some redemption as it looks for new revenue to back its flagging diabetes franchise.
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