Novo Nordisk falls on insulin briefing docs

Novo Nordisk A/S (CSE:NVO; NYSE:NVO) fell $14.35 to $145.27 in New York on Tuesday after FDA reviewers expressed concern with a cardiovascular safety signal for two of the company's insulin products under review for Type I and II diabetes. The reviewers said that a meta-analysis of CV events from 16 open-label trials showed that the risk of major adverse CV events (MACE) was "consistently higher" in pooled groups receiving Tresiba insulin Degludec and Ryzodeg insulin Degludec/insulin aspart vs. comparators. The comments came in briefing documents released ahead of Thursday's Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) meeting to discuss NDAs for the products. The committee will vote on whether Novo must conduct a CV outcomes trial for the products, but the question does not specify whether this should be conducted pre- or post-approval. Tresiba and Ryzodeg had an Oct. 29 PDUFA date. Novo has said it could not speculate on when a decision would be made until after the meeting.

The reviewers also questioned the "reliability" and "clinical relevance" of hypoglycemia data for Tresiba and Ryzodeg, noting that data from the clinical programs lacked consistency on predefined hypoglycemia secondary endpoints for both products. The reviewers said the data "do not suggest an advantage" of the products on the risk of hypoglycemia over comparators. Novo said in its own briefing documents that since Tresiba and Ryzodeg achieve similar reductions in HbA1c vs. comparators, the products' effect on hypoglycemia is a "key differentiator." ...