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Novo Nordisk A/S (NVO) - free report >>
Pacira BioSciences, Inc. (PCRX) - free report >>
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Novo Nordisk's IDegLira Review Period Extended in the U.S.
Novo Nordisk A/S (NVO - Free Report) announced that the FDA has extended the review period of its New Drug Application (NDA) for IDegLira for the treatment of adults with type II diabetes by another three months. A response from the FDA is expected in Dec 2016.
IDegLira is a once-daily, single-injection, fixed combination of Tresiba (insulin degludec) and Victoza (liraglutide).
We note that the NDA was submitted to the FDA in Sep 2015 under the agency’s Prescription Drug User Fee Act V (PDUFA V) regulation.
Currently, the product is marketed in six countries under the brand name Xultophy.
NOVO-NORDISK AS Price
NOVO-NORDISK AS Price | NOVO-NORDISK AS Quote
We remind investors that in May 2016, the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) voted unanimously (16-0) in favor of the approval of IDegLira. The recommendation was based on positive data from the DUAL study. Novo Nordisk has also evaluated Tresiba and Victoza in other studies.
Novo Nordisk has a strong presence in the Diabetes Care market, supported by one of the broadest diabetes portfolios in the industry, which comprises drugs like Victoza, Levemir and modern insulins. A potential approval of the product in the U.S. will further expand the company’s portfolio.
In 2016, the company expects sales to grow 5–7% on the back of strong performance of Tresiba and Victoza as well as by contributions from Saxenda and Xultophy.
Investor focus is expected to remain on the outcome of the FDA’s response on IDegLira.
Novo Nordisk carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Pacira Pharmaceuticals, Inc. (PCRX - Free Report) , Anika Therapeutics Inc. (ANIK - Free Report) and ANI Pharmaceuticals, Inc. (ANIP - Free Report) . All three stocks sport a Zacks Rank #1 (Strong Buy).
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