Sanofi/Re­gen­eron Dupix­ent; Alk­er­mes' an­tipsy­chot­ic get dates with the FDA; Con­cert wins re­prieve in In­cyte patent fight

→ Sanofi and Re­gen­eron’s bi­o­log­ic Dupix­ent, wide­ly con­sid­ered the best-in-class ther­a­py for atopic der­mati­tis is now up for FDA ap­proval in chil­dren aged 6 to 11. The US reg­u­la­tor has grant­ed its mak­ers pri­or­i­ty re­view for the in­di­ca­tion — and a fi­nal de­ci­sion is ex­pect­ed by May 26.

→ Alk­er­mes has al­so heard back from the US drug reg­u­la­tor. The com­pa­ny’s ex­per­i­men­tal oral an­tipsy­chot­ic for schiz­o­phre­nia and bipo­lar I dis­or­der — ALKS-3831 (olan­za­p­ine/sami­dor­phan) —which is de­signed to of­fer the ef­fi­ca­cy of olan­za­p­ine (once sold among oth­ers, as Lil­ly’s Zyprexa) while mit­i­gat­ing olan­za­p­ine-as­so­ci­at­ed weight gain is un­der FDA re­view. The agency is ex­pect­ed to make its de­ci­sion by No­vem­ber 15.

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