FDA to look again at Novo Nordisk insulin submissions

pharmafile | April 8, 2015 | News story | Research and Development, Sales and Marketing |  Novo Nordisk, Ryzodeg, Tresiba, diabetes, insulin degludec 

Diabetes specialist firm Novo Nordisk has resubmitted its applications for two insulins to the FDA, along with new interim safety data requested by the regulator.

The FDA had initially rejected the company’s original submission for Tresiba (insulin degludec) and Ryzodeq (insulin degludec/insulin aspart) in 2013. It issued a Complete Response Letter to the Danish firm demanding more data on cardiovascular safety from a dedicated cardiovascular outcomes trial before it could complete its review of the applications.

There are concerns that the drugs could be linked to higher rates of heart attacks or strokes.

Novo Nordisk now has interim data from the DEVOTE trial, a Phase III randomised controlled study comparing the safety of Tresiba and insulin glargine in people with type 2 diabetes who are at high risk of major cardiovascular events (dying from heart problems, or having a heart attack or a stroke).

Novo Nordisk does not yet have the full results of the trial, which is expected to be completed in the second half of 2016, but the FDA has accepted and is willing to proceed with a review based on interim data.

Industry analysts say Tresiba and Ryzodeg could be approved later this year based on the safety data. Tresiba, a long-acting form of insulin, is currently forecast to generate annual sales of $2.2 billion by 2020, according to Thomson Reuters Cortellis.

Novo Nordisk will be keen to secure a 2016 approval for two of the insulin products that it sees as competition to its main rival in the diabetic insulin market – Sanofi, which recently gained US and European approval for its new insulin, Toujeo (insulin glargine).

According to Reuters Novo Nordisk chairman Göran Ando has identified getting Tresiba approved by the FDA as one of the most important short-term goals for the company.

Lilian Anekwe