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From Fiercebiotech
The process is slightly further along in the U.S., where dupilumab has a PDUFA date of March 29 as a result of the FDA accepting it for priority review

Dupilumab, which is due to be sold as Dupixent, has acquired blockbuster-in-waiting status among analysts on the strength of a string of stellar data drops in a hard-to-treat population. Phase 3 data link the monoclonal antibody to a reduction in itching, clearing of skin lesions, decline on eczema clinical scales and the easing of anxiety and depression. The data mean dupilumab is tipped to make a difference to the lives of an underserved population—and rack up blockbuster sales doing so.
If everything goes to plan, commercial teams will avoid the slow start that blighted Regeneron and Sanofi’s introduction of Praluent. And the R&D units will push ahead with turning dupilumab into the one-drug franchise envisaged by Regeneron R&D chief George Yancopoulos