FDA grants pri­or­i­ty re­view for Dupix­ent in COPD, sets June ap­proval de­ci­sion dead­line

Sanofi and Re­gen­eron’s megablock­buster Dupix­ent just got one step clos­er to a land­mark ap­proval.

The FDA has grant­ed a pri­or­i­ty re­view with a tar­get dead­line of June 27 for an ap­proval de­ci­sion on Dupix­ent for a sub­set of chron­ic ob­struc­tive pul­monary dis­ease pa­tients, the drug­mak­ers said Fri­day. If ap­proved, it would be the first bi­o­log­ic to treat that form of COPD, a space where oth­er phar­ma ef­forts have stum­bled, like As­traZeneca’s Fasen­ra and GSK’s Nu­cala.

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