New insulin may get speedy FDA approval
Pharmaceutical manufacturer Novo Nordisk, based in Denmark, said it will re-submit its new insulin drug, Tresiba, to the Food and Drug Administration (FDA) for approval. The company could approval as early as this fall, which would signal a 2016 launch, according to Reuters.
Pharmaceutical manufacturer Novo Nordisk, based in Denmark, said it will re-submit its new insulin drug, Tresiba, to FDA for approval. The company could approval as early as this fall, which would signal a 2016 launch, according to Reuters.
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Novo Nordisk said it will file with the FDA in April, after favorable interim analysis data from a clinical trial data on Tresiba, which is already available in Europe and other markets. FDA rejected approval of the drug 2 years ago over concerns that it could be linked to higher rates of heart attacks or strokes. As a result, FDA asked Novo to conduct a dedicated cardiovascular risk trial.
Related: FDA approves new obesity device
Novo competes with Sanofi and Eli Lilly in supplying insulin to diabetics. Tresiba, an ultra-long-acting form of insulin, is forecast to generate annual sales of $2.2 billion by 2020, according to consensus estimates compiled by Thomson Reuters Cortellis, Reuters reported.
If Novo waited to submit results from the full trial, the drug would likely not have been launched in the United States in 2016.
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