After a delay of more than two years, Novo Nordisk has at last been granted approval in the United States for Tresiba and Ryzodeg, two drugs expected to consolidate its position as the leading diabetes company.
By 0307 EDT shares in Novo Nordisk were up 1.8 percent to be one of the best performers among top European shares .STOXX . Tresiba is already being sold in 30 countries, and analysts expect annual sales of $2.4 billion by 2020, according to Thomson Reuters Cortellis. “We intend to launch Tresiba in the USA market with a moderate premium”.
Despite having bagged clearance in Japan and Europe, Tresiba was rejected by the US Food and Drug Administration in February 2013 on heart safety concerns, with the agency demanding a new trial looking at the cardiovascular effects of the long-acting insulin. Novo Nordisk shares are heading in the right direction of their best day in six months.
Long-acting basal insulin Tresiba (insulin degludec) and combination drug Ryzodeg (insulin degludec and insulin aspart) will now be able to compete head-to-head in the market with Sanofi’s $7bn-a-year blockbuster Lantus (insulin glargine).
Novo Nordisk (NVO – Analyst Report) announced that Tresiba and Ryzodeg 70/30 have gained the long-awaited FDA approval for the treatment of diabetes mellitus in adults.
In a statement, Lars Reblen Sorensen, president and CEO of Novo Nordisk said, “We believe these products offer significant benefits and important treatment options for people with type 1 and type 2 diabetes”. The ongoing cardiovascular outcomes trial will likely conclude in mid-2016, Hobbs said. FDA notes that neither drug should be used in adults who have diabetic ketoacidosis. Novo Nordisk management does not have access to the results of the interim analysis.