Novo Nordisk has decided to halt its plans to file for FDA approval of IcoSema, a once-weekly combination therapy of insulin icodec and semaglutide, in 2024. This decision follows the FDA's recent rejection of insulin icodec as a standalone treatment, leading the company to reconsider its strategy for the IcoSema combination. The setback is significant, as IcoSema was anticipated to be a major advancement in diabetes treatment, offering patients a more convenient dosing schedule. Novo Nordisk is now evaluating the next steps for IcoSema and its potential future in the U.S. market.
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