COPENHAGEN Danish drugmaker Novo Nordisk said on Tuesday Japan's health regulator had approved its new combination insulin, that it plans to market as Ryzodeg, for the treatment of diabetes.
Ryzodeg is a combination of Novo's new ultra long-acting insulin degludec, or Tresiba, which Japan became the first country to approve in September, and its rapid-acting insulin Novorapid.
Tresiba, Novo's biggest new drug hope, had a setback in November when regulators in the United States, where Novo expects to generate the bulk of sales, said Tresiba has a higher heart safety risk than other diabetes treatments, raising fears that it may not be approved there.
Novo has also filed for approval of the drug in the European Union, Canada, Switzerland and other countries.
Tresiba and Ryzodeg are seen as strong new competitors in the long-acting, or basal, insulin market, which has long been dominated by Sanofi's Lantus. Competition is hotting up in the space, with Eli Lilly also having a promising new contender in development.
Novo has said previously that the exact timing for the launch of Ryzodeg would be decided after a price listing for Tresiba, which it plans to launch in Japan shortly after completion of price talks.
(Reporting via Stockholm newsroom; editing by Patrick Graham)