No sur­prise: Af­ter near unan­i­mous ad­comm, FDA re­jects Eli Lil­ly bid to bring Jar­diance to type 1 pa­tients

In an un­sur­pris­ing move, the FDA has re­buffed Eli Lil­ly and Boehringer In­gel­heim in their ef­forts to ex­pand the in­di­ca­tion for their best-sell­ing di­a­betes drug Jar­diance, is­su­ing a com­plete re­sponse let­ter.

The CRL came four months af­ter an FDA ad­vi­so­ry com­mit­tee vot­ed 14-2 against al­low­ing the two drug­mak­ers to mar­ket the drug for type 1 di­a­betes, say­ing the risks out­weighed the po­ten­tial ben­e­fits. The FDA does not pub­licly re­lease its re­jec­tion let­ters, but in a press re­lease, Eli Lil­ly ac­knowl­edged the rul­ing was “con­sis­tent with the out­come of the En­docrino­log­ic and Meta­bol­ic Drugs Ad­vi­so­ry Com­mit­tee in No­vem­ber.”

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