Lilly Unlucky? Lilly Leads Big Pharma In US FDA Complete Response Letters

Clinical concerns outweigh quality issues in big pharma CRLs, a Pink Sheet analysis finds, making mirikizumab – the fourth new product candidate sponsored by Lilly to receive a CRL since 2021 – even more of an outlier: it was turned back by FDA because of manufacturing concerns.

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The US FDA’s complete response letter for Eli Lilly and Company’s mirikizumab for ulcerative colitis cements the company’s position as the most frequent big pharma recipient of CRLs for original applications in recent years, the Pink Sheet’s US FDA Performance Tracker shows.

The 15 biggest pharma companies received CRLs for 14 new drug applications and biologics license applications from 2021 up to the 13 April 2023 mirikizumab CRL announcement

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