Lilly Strikes Out With The FDA For Second Time This Year With Mirikizumab CRL

Eli Lilly and Company started 2023 on a high, preparing for five big US Food and Drug Administration approvals of new products or new indications. The year is not going as smoothly as the company had hoped, however, with the FDA issuing a complete response letter (CRL) rejecting mirikizumab as a treatment for ulcerative colitis due to concerns about manufacturing for the IL-23 inhibitor.

The CRL, which Lilly announced on 13 April, gives the Indianapolis-based drug maker a 1-for-3 record so far this year, after the agency declined to grant the company’s request for accelerated approval of the anti-amyloid antibody donanemab in January. (Also see "US FDA Rejects Lilly’s Bid For Donanemab Accelerated Approval In Early Alzheimer’s" - Scrip, 20 January, 2023.) However, Lilly notched a win later in January when the FDA approved its BTK inhibitor, Jaypirca (pirtobrutinib), for third-line or later mantle cell lymphoma