A US FDA advisory committee will consider whether the benefits of once-weekly insulin icodec outweigh the significantly higher rate of hypoglycemic episodes in patients with type 1 disease. The agency appears satisfied with safety and efficacy in type 2 diabetics.
A broad indication for Novo Nordisk A/S’s once-weekly insulin icodec will be at issue when a US Food and Drug Administration advisory committee meets on 24 May to discuss an increased risk of hypoglycemia in patients with type 1 diabetes.
The Endocrinologic and Metabolic Drugs Advisory Committee will consider the risk of hypoglycemia with insulin icodec and proposed mitigation measures,...
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Upcoming FDA user fee goal dates include novel products from a busy lung cancer pipeline, a single-dose passive immunization against RSV for infants, what could be the first oral HAE acute treatment, and a first-in-class HAE preventive antibody.
This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.
