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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