Diabetes powerhouse Novo Nordisk has moved a step closer to winning Japanese approval for Ryzodeg, its new combination insulin product.
Ryzodeg (insulin degludec and insulin aspart) has passed the review by the First Committee on Drugs of Japan's Pharmaceutical Affairs, the final stage before approval by the country's Ministry of Health, Labour and Welfare (MHLW).
Novo Nordisk won approval for insulin degludec as a standalone product in September in Japan - the first market for the next-generation once-daily basal insulin - and is in the final stages of pricing negotiations before launching the drug there under the Tresiba brand name.
Ryzodeg combines Tresiba with Novo Nordisk's well-established fast-acting mealtime insulin NovoRapid (insulin aspart), which alongside NovoMix and Levemir accounts for the company's 25.4bn kroner ($4.3bn) in insulin analogue sales in the first nine months of the year.
The two new products are expected to make headway in the long-acting basal insulin sector, currently dominated by Sanofi's $5bn-a-year blockbuster product Lantus (insulin glargine), thanks to a low tendency to cause low blood sugar.
In Europe, the Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion on Tresiba and Ryzodeg on October 18, and marketing authorisation is expected within the next few weeks.
In the US, an FDA advisory committee recommended approval of both Tresiba and Ryzodeg last month, provided Novo Nordisk agrees to carry out a post-approval outcomes study to examine the drugs' cardiovascular safety.
EvaluatePharma recently forecast that sales of the Tresiba/Ryzodeg franchise could reach $1.4bn by 2016, and Novo Nordisk has been ramping up its salesforce in the US and elsewhere as it prepares for launch.
Other analysts have predicted peak sales of up to $4bn if physicians agree with Novo Nordisk's position that insulin degludec's long and predictable pharmacological action profile and convenient dosing will make it a compelling prescribing option.