FDA briefing papers for Novo Nordisk's insulin degludec note need to review cardiac risks

The  US Food and Drug Administration yesterday published the briefing documents ahead of the Advisory Committee meeting to discuss the New Drug Applications for Danish diabetes major  Novo Nordisk’s (NOV: N) insulin degludec and insulin degludec/insulin aspart, which will take place on November 8.

These indicated that some safety concerns should be considered by the independent panel of experts, news of which saw Novo Nordisk's share fall 6.9% to 860 Danish kroner by close of trading yesterday.

The new ultra long acting insulins, Tresiba (insulin degludec) and Ryzodeg (insulin degludec/insulin aspart), which are approved in Japan and have recently received a recommendation for approval from the European Medicines Agency advisory committee, the CHMP (The Pharma Letter October 22), have been forecast as generating sales of $1.4 billion by 2016, but that target is based on approval in the USA, the largest market potential. Earlier this year, the FDA delayed making a decision (TPL June 8).