Novo Nordisk (NVO) announced that the Committee for Medicinal Products for Human Use (CHMP) has recommended Tresiba (once daily basal insulin) for expanded use in patients in the age group of 1 year – 17 years who are suffering from diabetes.
While it is not mandatory for the European Commission (EC) to follow the CHMP’s recommendation, it usually does so.
According to the International Diabetes Federation, approximately 497,100 children across the world suffer from type I diabetes with a rise observed in the rate of type II diabetes among children. Novo Nordisk said that, upon approval, Tresiba can be prescribed to patients suffering from both type I and type II diabetes in the given age group.
Tresiba (once-daily) is already approved in Europe as a monotherapy and in combination with oral anti-diabetic medicinal products or mealtime insulin in adults suffering from type I and type II diabetes. Additionally, Tresiba received approval in May 2014 in combination with GLP-1 receptor agonists.
Our Take
We are encouraged by the CHMP’s recommendation for Tresiba’s label expansion. With NovoMix slated to lose patent protection in the EU (2014-2015) and the U.S. (2017) as well as a number of other products including NovoRapid and Norditropin in 2017, label expansion for Tresiba is expected to boost the top line.
We remind investors that Tresiba is being evaluated in a cardiovascular outcomes study (DEVOTE) initiated in Oct 2013. With patient enrolment progressing ahead of plans, Novo Nordisk expects sufficient data by the first half of 2015 to support a pre-specified interim analysis of the study. Based on interim data, the company will decide whether it will submit the results of this interim analysis to the FDA or wait for the completion of the study. The study should be completed in the 2016–2017 timeframe.
Novo Nordisk carries a Zacks Rank #4 (Sell). Some better-ranked stocks in the health care sector are Biogen Idec Inc. (BIIB), Allergan Inc. (AGN) and AbbVie Inc. (ABBV). While Biogen carries a Zacks Rank #1 (Strong Buy), Allergan and AbbVie hold a Zacks Rank #2 (Buy).
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