FDA re­jects Lil­ly's ul­cer­a­tive col­i­tis drug mirik­izum­ab over man­u­fac­tur­ing is­sues

US reg­u­la­tors de­clined to ap­prove Eli Lil­ly’s ul­cer­a­tive col­i­tis drug mirik­izum­ab, the com­pa­ny said, cit­ing man­u­fac­tur­ing is­sues.

Mirik­izum­ab is an an­ti­body that tar­gets IL-23, and Lil­ly has al­so been study­ing the drug in Crohn’s dis­ease. The In­di­anapo­lis-based drug­mak­er sub­mit­ted it to the FDA for ap­proval last year on the ba­sis of a Phase III tri­al that showed su­pe­ri­or­i­ty to place­bo.

In a press re­lease an­nounc­ing the com­plete re­sponse let­ter, Lil­ly said the FDA had raised “is­sues re­lat­ed to the pro­posed man­u­fac­tur­ing” of the drug, but not to its ef­fi­ca­cy or safe­ty.

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