Novo NordiskNVO announced that the FDA's Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) voted unanimously (16-0) in favor of the approval of IDegLira for the treatment of adults with type II diabetes.
IDegLira is a once-daily, single injection, fixed combination of Tresiba (insulin degludec) and Victoza (liraglutide).
Although the FDA takes the recommendations of its advisory committee into account while reviewing applications, it is not bound to follow the same.
The recommendation for approval was based on positive data from a clinical trial - DUAL. Novo Nordisk has also evaluated Tresiba and Victoza in separate clinical trials. We note that the new drug application (NDA) for IDegLira was submitted to the FDA in Sep 2015 under the agency's Prescription Drug User Fee Act V (PDUFA V) regulation.
The drug was approved in Sep 2014 in Europe and is currently sold under the brand name, Xultophy.
A potential approval of the drug in the U.S. will further broaden Novo Nordisk's portfolio. the company has a strong presence in the Diabetes Care market supported by one of the broadest diabetes portfolios in the industry that comprises drugs like Victoza, Levemir and modern insulins.
The company expects sales to grow 5-9% in 2016, driven by continually strong performance of modern insulins Tresiba and Victoza as well as by contributions from Saxenda and Xultophy.
Novo Nordisk carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the healthcare sector include Abbott Laboratories ABT , Johnson & Johnson JNJ and Sanofi SNY . All three stocks carry a Zacks Rank #2 (Buy).
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