FDA of­fers quick thumbs up to ex­pand Dupix­en­t's atopic der­mati­tis la­bel as Re­gen­eron/Sanofi plot block­buster moves

Sanofi and Re­gen­eron have racked up an­oth­er ap­proval for their block­buster hope­ful Dupix­ent as the FDA comes through fol­low­ing a pri­or­i­ty re­view.

The IL-4/IL-13 in­hibitor, which gen­er­at­ed $882 mil­lion (€783 mil­lion) in world­wide sales in 2018, can now ex­tend its reach to ado­les­cents with mod­er­ate to se­vere atopic der­mati­tis.

“For the first time, ado­les­cents with un­con­trolled mod­er­ate-to-se­vere atopic der­mati­tis have an ap­proved bi­o­log­ic treat­ment op­tion to help con­trol per­sis­tent, of­ten de­bil­i­tat­ing symp­toms such as chron­ic itch and wide­spread rash,” said George Yan­copou­los, Re­gen­eron’s $REGN  pres­i­dent and CSO, in a state­ment.

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