Novo Nordisk’s Tresiba & Ryzodeg Gain Entry into the U.S.

Novo Nordisk NVO announced that Tresiba and Ryzodeg 70/30 have gained the long-awaited FDA approval for the treatment of diabetes mellitus in adults.

Novo Nordisk intends to launch Tresiba in the U.S. during the first quarter of 2016. The drug will be available in the FlexTouch device in two formulations enabling maximum doses of 80 units and 160 units per injection.

We remind investors that on Mar 26, 2015, Novo Nordisk had announced its decision to submit results from a pre-specified interim analysis of a cardiovascular outcomes study, DEVOTE, to the FDA as part of a Class II resubmission of the new drug applications (NDAs) for Tresiba and Ryzodeg. The DEVOTE study is being conducted per requirements mentioned in a complete response letter served by the FDA related to Tresiba and Ryzodeg in Feb 2013. The study is expected to be complete by mid-2016.

Novo Nordisk said that in order to preserve integrity of the DEVOTE study the company has maintained a small team, which enjoys access to data from the study.

Meanwhile, Novo Nordisk has submitted an NDA for Xultophy to the FDA. The company is looking to get it approved in the U.S. for the treatment of type II diabetes. While Tresiba and Ryzodeg are already approved for the treatment of type I and type II diabetes in Europe and Japan, Xultophy is approved in the EU for the treatment of type II diabetes mellitus in adults.

Additionally, Novo Nordisk announced encouraging headline results from the second phase IIIa study (SUSTAIN 3) on its once-weekly GLP-1 analogue, semaglutide. The study showed that patients treated with semaglutide (1.0 mg) achieved a statistically significant and superior improvement of 1.5% in HbA1c compared to a 0.9% improvement in HbA1c in patients receiving a once-weekly dose of AstraZeneca’s AZN Bydureon (2.0 mg) from a mean baseline HbA1c of 8.4%.

Novo Nordisk carries a Zacks Rank #2 (Buy). Other well-ranked stocks in the health care sector include Abbott Laboratories ABT and Eli Lilly and Company LLY. Both carry the same Zacks Rank as Novo Nordisk.

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