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Sanofi Diabetes Combination Drug FDA Action Date Extended
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French drugmaker Sanofi (SNY - Free Report) is looking at a three month delay in the FDA action date for its once-daily fixed-ratio combination of Lantus (basal insulin glargine 100 Units/mL) and GLP-1 receptor agonist Adlyxin (ex-U.S. trade name: Lyxumia; lixisenatide) for the treatment of adults with type II diabetes.
The company announced that it has submitted updated information on the pen delivery device as part of its New Drug Application (NDA) for the fixed-ratio combination.
The information was submitted at the FDA’s request and constitutes a Major Amendment to the NDA. As a result, the FDA action date for the combination treatment has been extended by three months to Nov 2016.
We remind investors that in late May 2016, the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) had voted in favor (12 to 2) of approving the fixed-ratio combination.
We note that Sanofi had gained FDA approval for Adlyxin a few weeks ago in late July. Sanofi’s Diabetes franchise is under significant pressure with key product, Lantus, facing increasing competitive pressure at the payor level and biosimilar competition in several European markets. Lantus has been a major contributor to the company’s top line having accounted for 17.2% of total sales in 2015.
Considering recent market trends, Sanofi expects its global Diabetes sales to decline 4–8% annually over the 2015–2018 timeframe.
Sanofi is a Zacks Rank #4 (Sell) stock. Some better-ranked stocks in the health care sector include Actelion Ltd. , Cambrex Corporation and Geron Corporation (GERN - Free Report) – all three are Zacks Rank #1 (Strong Buy) stocks. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report >>
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Sanofi Diabetes Combination Drug FDA Action Date Extended
French drugmaker Sanofi (SNY - Free Report) is looking at a three month delay in the FDA action date for its once-daily fixed-ratio combination of Lantus (basal insulin glargine 100 Units/mL) and GLP-1 receptor agonist Adlyxin (ex-U.S. trade name: Lyxumia; lixisenatide) for the treatment of adults with type II diabetes.
The company announced that it has submitted updated information on the pen delivery device as part of its New Drug Application (NDA) for the fixed-ratio combination.
The information was submitted at the FDA’s request and constitutes a Major Amendment to the NDA. As a result, the FDA action date for the combination treatment has been extended by three months to Nov 2016.
We remind investors that in late May 2016, the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) had voted in favor (12 to 2) of approving the fixed-ratio combination.
We note that Sanofi had gained FDA approval for Adlyxin a few weeks ago in late July. Sanofi’s Diabetes franchise is under significant pressure with key product, Lantus, facing increasing competitive pressure at the payor level and biosimilar competition in several European markets. Lantus has been a major contributor to the company’s top line having accounted for 17.2% of total sales in 2015.
Considering recent market trends, Sanofi expects its global Diabetes sales to decline 4–8% annually over the 2015–2018 timeframe.
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Sanofi is a Zacks Rank #4 (Sell) stock. Some better-ranked stocks in the health care sector include Actelion Ltd. , Cambrex Corporation and Geron Corporation (GERN - Free Report) – all three are Zacks Rank #1 (Strong Buy) stocks. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report >>