(News Bulletin 247) – Eli Lilly announced last night that the US Food and Drug Administration (FDA) had rejected its authorization request for mirikizumab, a new treatment for ulcerative colitis.
The pharmaceutical group indicates that it has received from the United States health authority a ‘complete response letter’ (CRL), that is to say a letter that the FDA sends to the laboratories to tell them that their file cannot be approved as it stands.
In its press release, Lilly specifies however that the concerns raised by the FDA concern the manufacturing process of the product, not its supposed effectiveness or the clinical data which it has been the subject of.
The Indianapolis group is therefore ‘confident’ in its drug and plans to cooperate closely with the FDA in order to quickly put it on the American market.
Mirikizumab is already approved in Japan and has received a positive recommendation from a European Medicines Agency (EMA) committee for future approval in Europe.
Following these announcements, the Eli Lilly action limited its decline on Friday morning on the New York Stock Exchange, yielding around 0.4% in the first trade.
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