Please login to the form below

Not currently logged in
Email:
Password:

Novo Nordisk says Ryzodeg nears Japanese approval

Combination of Tresiba and NovoRapid expected to compete with Sanofi’s Lantus

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.

4th December 2012

From: Sales

Share

Tags

Featured jobs

Subscribe to our email news alerts

PMHub

Add my company
Star

Established in 2002, Star is a full service outsourcing and resourcing company that works with the best people and opportunities...

Latest intelligence

BrAInPME.png
The future of medical content: The personal touch
The purpose of delivering personalised content to HCPs is not just about customer experience, it's about improving healthcare. Our Commercial Director, Tib Catania discusses what ‘deep learning’ means for the...
Rise of the patient expert - an interview with Michael Seres
Founded by Michael Seres in 2011, 11 Health is a connected medical device company currently working to change the lives of patients using stoma bags. Content Marketing Manager Liz Inskip...
Making sense of Nutraceuticals in China
Published in eyeforpharma February 2017 by Marc Yates...

Infographics