Novo Nordisk, a global healthcare company, announced that Ryzodeg (insulin degludec/insulin aspart) has passed the review by the First Committee on Drugs of Japan’s Pharmaceutical Affairs. The remaining step in the regulatory process is an approval from the Ministry of Health, Labour and Welfare.
The First Committee on Drugs of Pharmaceutical Affairs serves as an advisory body to the Ministry in matters related to pharmaceuticals including new drug applications. The passing of the review by the drug committee is an essential milestone in the Japanese review process prior to a marketing authorisation from the Ministry.
Novo Nordisk expects to receive marketing authorisation from the Ministry within a few months.
In Japan, price negotiations for Tresiba (insulin degludec) continue and are expected to be completed in the first quarter of 2013. The exact launch timing for Ryzodeg is to be decided after the Tresiba price listing.
Tresiba is the intended brand name for insulin degludec, the first once-daily new generation basal insulin analogue, with an ultra-long duration of action, discovered and developed by Novo Nordisk. Tresiba has a distinct slow absorption which provides a flat and stable action profile. Tresiba has been studied in a large-scale clinical trial programme, BEGIN, examining its impact on glucose control, hypoglycaemia and the possibility to flexibly adjust Tresiba dosing time to suit patient needs.
Ryzodeg is the intended brand name for insulin degludec/insulin aspart, which contains the new-generation basal insulin degludec in a formulation with a bolus boost of insulin aspart. Ryzodeg is the first and only soluble insulin combination of ultra-long-acting insulin degludec and the most prescribed rapid-acting insulin, NovoRapid (NovoLog in the US), providing both fasting and post-prandial glucose control.
Tresiba and Ryzodeg were submitted for regulatory approval to the Japanese Ministry of Health, Labour and Welfare (MHLW) in December 2011 and March 2012, respectively. Tresiba was approved in Japan in September 2012 and in October 2012 Tresiba and Ryzodeg received positive CHMP opinions in Europe. In November, the products received a positive vote for approval from an FDA Advisory Committee. In addition, applications have been submitted for regulatory approval in Canada, Switzerland and a range of other countries.