More Data on Novo Nordisk's Tresiba

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Novo Nordisk (NVO) presented new data on its type II diabetes drug, Tresiba at the annual meeting of the European Association for the Study of Diabetes (:EASD).

Data was presented from a 26-week add-on study on Tresiba. Patients were divided into three arms: patients with HbA1c below 7% received once-daily Tresiba and metformin; patients with HbA1c above 7% were randomized to receive either once-daily Victoza or once-daily NovoRapid in addition to once-daily Tresiba plus metformin.

Data revealed that the majority of type II diabetes patients receiving the recently launched Tresiba plus metformin were able to maintain good glycemic control for 2.5 years. 80.5% of these patients maintainedHbA1c below 7% when continuing treatment with Tresiba and metformin. These patients had mean HbA1c of 6.5% at week 26. Durability and efficacy of Tresiba were also revealed in the study. The rate of overall confirmed hypoglycemic episodes was 2.64/patient-year of exposure (:PYE), and the rate of nocturnal confirmed hypoglycemic episodes was 0.20/PYE.

The addition of Victoza to Tresiba and metformin was more effective in helping patients achieve their glycemic targets as against adding NovoRapid. On adding Victoza, the mean HbA1c was 7% compared to 7.3% on the addition of NovoRapid. On adding Victoza, HbA1c was reduced by 0.74% as compared to 0.39% on the addition of NovoRapid.

Tresiba is already approved in the EU (Jan 2013) and Japan (2012). However, U.S. approval is yet to come - the U.S. Food and Drug Administration (:FDA) declined to approve Tresiba on the basis of submitted data and issued a complete response letter (CRL) on Feb 10, 2013. The FDA has asked Novo Nordisk to conduct a dedicated cardiovascular outcomes study and provide additional cardiovascular data. Novo Nordisk received a feedback from the FDA regarding the cardiovascular outcomes study protocol for Tresiba and expects to start the study by year end.

Novo Nordisk currently carries a Zacks Rank #2 (Buy). Other large cap pharma stocks that look well-placed include Roche Holding (RHHBY), Eli Lilly and Company (LLY)  and Bayer (BAYRY).  Roche carries a Zacks Rank #1 (Strong Buy) while Bayer and Eli Lilly carry Zacks Rank #2.

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