Novo Wins EU Regulatory Backing for Weekly Diabetes Drug Kyinsu


Novo Nordisk A/S’s once-weekly diabetes drug was recommended for approval in the European Union, paving the way for patients to be able to access another option to control their condition.

The European Medicines Agency’s drug review panel recommended approval for Kyinsu in patients with type 2 diabetes. The combination injection of insulin and semaglutide — the active ingredient in Novo’s blockbuster drug Ozempic — is also known as IcoSema.

Trials of the drug show it can help patients with type 2 diabetes control their weight and low blood sugar more than daily injections of insulin. It can be helpful for patients who are unable to control their diabetes with daily insulin.

The long-acting insulin portion of the drug had previously been rejected by the US Food and Drug Administration, which asked for more detail on the manufacturing process and the type 1 diabetes indication.

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