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Novo Nordisk: Positive CHMP Nod for Tresiba Label Expansion

Zacks Equity Research

Novo Nordisk A/S NVO announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), has issued a positive opinion suggesting an update to the label for Tresiba (insulin degludec) to include data from the SWITCH studies.

Novo Nordisk’s share price shows that the company has underperformed the Zacks classified Large Cap Pharmaceuticals industry year to date. The stock declined 4.4% compared to the industry’s gain of 6.9%.

Tresiba is a long-acting human insulin analog indicated to improve glycemic control in patients aged between one year or more with diabetes mellitus.

For the SWITCH 1 and the SWITCH 2 trials, the CHMP suggested that the label should be updated include results showing that Tresiba led toconsiderable reductions in hypoglycaemia. In the SWITCH 1 study, adults with type I diabetes and in SWITCH 2 trial adults with type II diabetes were treated with Tresiba versus insulin glargine U100, both in addition to meal-time insulin. In both the studies, the patients experienced statistically significant reductions in hypoglycaemia when treated with Tresiba compared to insulin glargine.

The CHMP’s positive opinion will be referred for final action to the European Commission and the company expects to receive the updated marketing authorisation in the second quarter of 2017.

Further, the CHMP also granted positive opinion to Novo Nordisk’s pipeline candidate nonacog beta pegol, N9-GP, recommending marketing authorisation for the treatment of adolescents and adults with haemophilia B. The candidate will be marketed by the trade name of Refixia. The recommendation was based on the results from the paradigm clinical trial program where 115 previously treated children and adults with haemophilia B were treated with Refixia. 

In a separate press release, the company also announced that Fiasp, a new fast-acting mealtime insulin for the treatment of diabetes in adults, has been launched in Canada, following the marketing authorisation from Health Canada in January this year. The launch of Fiasp in Canada represents first new mealtime insulin in 10 years. 

All these bode well for Novo Nordisk and once Tresiba and Refixia get approved in the EU as well, it should lead to increased revenues for the company.

Novo Nordisk A/S Price


Novo Nordisk A/S Price | Novo Nordisk A/S Quote

Zacks Rank & Stocks to Consider

Novo Nordisk currently carries a Zacks Rank #3 (Hold). Some other better-ranked stocks in the health care sector include Heska Corp. HSKA, Retrophin, Inc. RTRX and Addus HomeCare Corp. ADUS. While Heska and Retrophin sport a Zacks Rank #1 (Strong Buy), Addus HomeCare carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Heska’s earnings estimates increased from $1.53 to $1.65 for 2017 and from $1.80 to $2.01 for 2018, over the last 30 days. The company posted a positive earnings surprise in all of the four trailing quarters with an average beat of 291.54%. Its share price increased 37% year to date.

Retrophin’s loss estimates narrowed from 85 cents to 72 cents for 2017 and from 67 cents to 53 cents for 2018, over the last 30 days. The company posted a positive earnings surprise in three of the four trailing quarters with an average beat of 80.55%.  

Addus HomeCare earnings estimates increased from $1.38 to $1.41 for 2017, over the last 30 days. The company posted a positive earnings surprise in two of the four trailing quarters with an average beat of 10.14%.

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