Novo Nordisk’s bid for once-weekly slow-acting insulin, icodec, has been rejected by the FDA due to concerns about manufacturing processes and use in type 1 diabetes patients. The FDA advisory committee also raised issues about higher rates of hypoglycemia with icodec compared to daily injections. This setback comes as rival Eli Lilly’s once-weekly insulin, efsitora alfa, showed positive results in type 2 diabetes patients. Other recent regulatory news includes approvals for drugs treating atopic dermatitis, Alzheimer’s disease, COPD, leukocyte adhesion deficiency-I, CIDP, and solid tumors. The FDA is considering changes to biosimilar switching study requirements, while PTC Therapeutics faces challenges with renewing marketing authorization in Europe for its Duchenne therapy, Translarna.
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FDA Says ‘No’ to Novo Nordisk’s Once-Weekly Insulin
