FDA tees up a snap review for Dupixent as Sanofi, Regeneron hunt 4th approval for megablockbuster
With competitor after competitor going after Dupixent for indications such as atopic dermatitis, is it finally the drug’s turn to concede and drop? Well, if Sanofi and Regeneron can help it, not even close.
The megablockbuster drug that Sanofi and Regeneron have collaborated over is back before the FDA, the companies announced early Monday — following the FDA accepting an sBLA for a new indication: eosinophilic esophagitis (EoE), a chronic inflammatory disease and allergic condition that can impact a person’s ability to swallow. As the pharmas are looking to get approval for the drug in patients 12 and older, the FDA granted Dupixent priority review — an FDA designation that speeds up the agency’s review process from normally a 10-month timeframe up to within 6 months. Sanofi and Regeneron were given a PDUFA date of August 3rd.
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