Novo Nordisk has suffered another setback in its bid to get approval in the USA for its ultra long-acting insulin degludec and insulin combination analogue degludec/aspart after regulators said the drugs will face an advisory panel.
Last month, the US Food and Drug Administration extended the regulatory review period for degludec and the aforementioned combo for type 1 and 2 diabetes by three months. The agency asked for "further data clarification and analyses" and Novo had already submitted "a substantial amount" of that additional information.
A decision on the drugs, which if approved will be known as Tresiba and Ryzodeq respectively, was therefore put back to October 29. However, the FDA has now informed the Danish drugmaker that instead of an action date, an advisory committee meeting has been pencilled in for November 8.
This means that any hopes Novo had of launching the products this year have pretty much gone up in smoke. The drugs have also been filed with the European Medicines Agency and regulators in Japan, Canada, Switzerland and a range of other countries.
Novo sees degludec as a competitor to Sanofi's blockbuster Lantus (insulin glargine), the biggest-selling insulin product in the world.