Shares in Novo Nordisk have soared this morning after a US Food and Drug Administration panel recommended approval of Tresiba and Ryzodeq, despite expressing concerns over possible cardiovascular risk of the ultra long-acting insulins.
The agency's Endocrinologic and Metabolic Drugs Advisory Committee voted 8-4 in favour of approving Tresiba (insulin degludec) and Ryzodeg (insulin degludec/insulin aspart). However the panel unanimously recommended that a cardiovascular outcomes trial should be conducted, something which Novo expects will cost 1.50 billion Danish kroner (about $256 million) over the next six years.
The fact that Novo would only have to conduct the trial post-approval is a major boost for the company. The FDA has not said when it expects to complete its review but analysts believe the green light is now very likely in the near future; Tresiba has been approved in Japan and advisors to the European Medicines Agency issued a positive opinion last month.
However, approval in the USA is key, although Novo is being coy about making any sales forecasts until it sees the labelling on Tresiba and Ryzodeg. The company is hoping that the new drugs will challenge Sanofi's blockbuster Lantus (insulin glargine), the biggest-selling insulin product in the world.
Investors believe approval is around the corner and Novo shares were up 7.8% at 11.15 this morning (UK time) to 932 kroner.