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

Agency Denied Donanemab Accelerated Approval In January

 
• By Mandy Jackson

With mirikizumab delayed until Lilly overcomes the FDA’s manufacturing concerns, the company has fallen behind on its goal of five approvals in 2023.

Skid marks in front of speed bump on a asphalt country road
The mirikizumab CRL is Lilly's second bump in the road with the FDA in 2023 • Source: Shutterstock

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,...

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