Novo Nordisk Dismayed By “Complete Response” Letter For Insulin Degludec
This article was originally published in The Pink Sheet Daily
FDA is requesting data from a dedicated cardiovascular outcomes trial before approving the ultra-long-acting insulins Tresiba and Ryzodeg. News of the regulatory setback caused a 13% drop in the company’s stock price on Feb. 11.
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After initial rejection and resubmission, FDA approves ultra-long-acting insulin Tresiba, and also Ryzodeg, which combines Tresiba and the company’s meal-time insulin NovoLog.
ICER is likely to consider whether Novo Nordisk's Tresiba can be differentiated from other long-acting insulins and the potential size of the patient population for GlaxoSmithKline's asthma drug, Nucala.
Firm is aiming to make Tresiba the first basal insulin to carry a claim for reduced risk of hypoglycemia.