Albert Bourla, Pfizer CEO (Laurent Gillieron/Keystone via AP)

FDA and EMA ac­cept Pfiz­er’s reg­u­la­to­ry sub­mis­sions for ul­cer­a­tive col­i­tis drug

Pfiz­er’s S1P re­cep­tor mod­u­la­tor for treat­ing ul­cer­a­tive col­i­tis, etrasi­mod, which was at the cen­ter of a bil­lion-dol­lar buy­out from Are­na Phar­ma, has now tak­en an­oth­er step for­ward.

On Wednes­day, the phar­ma an­nounced that the FDA had ac­cept­ed for re­view the NDA for etrasi­mod in pa­tients with “mod­er­ate­ly-to-se­vere­ly ac­tive” ul­cer­a­tive col­i­tis. Pfiz­er stat­ed that the FDA’s de­ci­sion will be ex­pect­ed in the sec­ond half of next year. Mean­while, the EMA has al­so ac­cept­ed the mar­ket­ing au­tho­riza­tion ap­pli­ca­tion for the drug in the same pa­tient pop­u­la­tion, with that de­ci­sion ex­pect­ed some­time in the first half of 2024.

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