Novo Nordisk is expected to find out in October whether FDA will approve its long-acting insulin Tresiba for sale in the US market. However, if approved, Tresiba faces growing competition from Sanofi, which markets the leading basal insulin Lantus along with Toujeo.
Novo Nordisk is expected to find out in October whether FDA will approve its long-acting insulin Tresiba (insulin degludec) for sale in the US market. However, if approved, Tresiba faces growing competition from Sanofi, which markets the leading basal insulin Lantus (insulin glargine) along with Toujeo (insulin glargine injection).
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In addition, Sanofi has negotiated “good access” with pharmacy benefit managers for Toujeo at a lower price point, Lars Rebien Sorensen, Novo Nordisk's president and CEO, told investors during a recent earnings call, according to Medical Marketing & Media.
The FDA label “will determine how strong we are in the negotiations [with pharmacy benefit managers] and how strong we are in that competitive marketplace,” Rebien Sorensen said.
Novo Nordisk resubmitted Tresiba for FDA review in April, after US regulators delayed the review in 2013. FDA rejected the application 2years ago over concerns about higher rates of heart attacks or strokes when taking Tresiba.
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However, after Novo Nordisk submitted results from an interim clinical trial, FDA accepted the applicaton for Tresiba.
Tresiba is already available in about 30 countries.
Despite competition from Sanofi, Novo Nordisk said that sales of its 2 leading diabetes drugs-Victoza (liraglutide) and Levemir (insulin detemir [rDNA origin] injection),-soared 22% and 10%, respectively, in the first half of 2015.
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