Novo Nordisk A/S NVO announced its decision to submit the results from the pre-specified interim analysis of the DEVOTE study (a cardiovascular outcomes study on Tresiba) to the FDA as part of a Class II resubmission of the new drug applications (NDAs) for Tresiba and Ryzodeg. The resubmission is expected to take place by Apr 2015.
We remind investors that on Feb 8, 2013 Novo Nordisk had received a complete response letter from the FDA for Tresiba and Ryzodeg. In the letter, the FDA asked for additional cardiovascular data from a dedicated cardiovascular outcomes study before further review of the NDAs. Novo Nordisk commenced the cardiovascular outcomes trial on Tresiba (DEVOTE) in Oct 2013 and accumulated the required number of major adverse cardiovascular events for a pre-specified interim analysis by the end of Jan 2015.
Novo Nordisk stated that the Class II resubmission of NDAs will comprise a safety update including data from all studies conducted on Tresiba and an overview of post-marketing data. Additionally, the company mentioned that being a preliminary estimate based on a substantially low number of observations, the interim analysis results will be associated with a higher level of uncertainty compared to the results from the final analysis of the study.
Once the resubmission is completed, a response from the FDA is expected in a month. The FDA may either accept the filing or issue an ‘Incomplete Response Letter’ on the submission.
We note that Tresiba and Ryzodeg are both approved in the EU and Japan for type I and type II diabetes.
Meanwhile, Novo Nordisk will continue with the DEVOTE study, which was fully enrolled by the fourth quarter of 2014. The study should be completed by the second half of 2016.
Novo Nordisk carries a Zacks Rank #2 (Buy). Other well-ranked stocks in the health care sector include ANI Pharmaceuticals, Inc. ANIP, Cytokinetics, Inc. CYTK and Horizon Pharma plc HZNP. All these stocks carry a Zacks Rank #1 (Strong Buy).
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