The European Committee for Medicinal Products for Human Use (CHMP) recently recommended the approval of extended use of Novo Nordisk’s (NYSE: NVO - News) Levemir (insulin detemir) in children aged two to five years with type I diabetes.
Data from a study of Levemir demonstrated that children aged two to five years, who were treated with Levemir plus NovoLog, experienced a lower rate of all-day and nocturnal hypoglycaemia, compared to those taking human basal insulin NovoLog.
Novo Nordisk currently markets NovoLog to control high blood glucose in patients with diabetes.
The company also said that CHMP has recommended the use of Levemir as add-on therapy to Victoza (liraglutide), in combination with metformin in patients with type II diabetes. Novo Nordisk currently markets Victoza as a treatment for type II diabetes.
The CHMP’s opinion is based on data from a 52-week trial that was conducted to evaluate the safety and efficacy of once-daily Levemir when added to Victoza 1.8 mg plus metformin.
Earlier during this month, Novo Nordisk reported data from two trials of Victoza. The first trial showed that using Victoza at an early stage in the treatment of patients with type II diabetes, who had not received any treatment before or previously received only one oral anti-diabetic drug (OAD), led to greater improvements in glycaemic control than those who had been dosed two or more OAD’s.
The second trial showed that when type II diabetes patients switched from oral treatment with Merck & Co.’s (NYSE: MRK - News) Januvia to injectable Victoza (once daily), they experienced increased treatment satisfaction as well as significant reductions in blood glucose and body weight.
So far, we are impressed by Novo Nordisk’s biggest drug Victoza’s performance. Victoza is doing well both in the US and Europe. Moreover, we believe that the next-generation insulin analogues, Degludec and DegludecPlus, also hold significant importance for long-term growth at Novo Nordisk. Though we are encouraged by data on Degludec, we prefer to remain on the sidelines until we get more visibility on the approvability of Degludec and DegludecPlus. We currently have a Neutral recommendation on Novo Nordisk. The stock carries a #3 Rank (Hold rating) in the short-run.MERCK & CO (MRK): Read the Full Research ReportZacks Investment Research