Updates on the regulatory front are eagerly awaited by investors in the pharma/biotech sector as they impact the share price of the concerned company. Regulatory updates include events like filing of marketing applications, acceptance of these applications for review by the regulatory agencies, reviews by advisory panels and finally, a response from the regulatory agency regarding the approval status.
Earlier this week, Novo Nordisk A/S NVO announced that the Class II Resubmissions of its new drug applications (NDAs) for Tresiba and Ryzodeg have been accepted by the FDA for review.
The company said that a small team within the company has been given access to data from the DEVOTE study. This team will be responsible for interacting with the FDA during the review of the NDAs. This arrangement has been made to preserve the integrity of the DEVOTE study.
We remind investors that in Mar 2015, Novo Nordisk announced its decision to submit results from a pre-specified interim analysis of the DEVOTE study to the FDA as part of a Class II resubmission of the NDAs for Tresiba and Ryzodeg. The cardiovascular outcomes study, DEVOTE, is being conducted as per requirements mentioned in a complete response letter served by the FDA on Tresiba and Ryzodeg in Feb 2013.
Novo Nordisk maintained that being a preliminary estimate based on a substantially low number of observations, interim analysis results will be associated with a higher level of uncertainty compared to those from the final analysis of the study. The study should be completed by the second half of 2016.
We note that Tresiba and Ryzodeg are both approved in the EU and Japan for type I and type II diabetes.
Meanwhile, Novo Nordisk is developing a faster-acting insulin aspart for the treatment of type I and type II diabetes. The company intends to file for its approval in the U.S. and the EU by 2015-end or early 2016.
Novo Nordisk carries a Zacks Rank #4 (Sell). Some better-ranked stocks in the health care sector are ANI Pharmaceuticals, Inc. ANIP, Cytokinetics, Incorporated CYTK and Horizon Pharma plc HZNP. All these stocks carry a Zacks Rank #1 (Strong Buy).
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