The US Regulatory Authorities Approve Novo's New Diabetes Drug 'Tresiba'

The US Food and Drug Administration’s approval was based on the clinical trials that showed the drug, Tresiba can improve glycemic control.

The US Food and Drug Administration approved the new Tresiba diabetes drug from Danish drugmaker Novo Nordisk.

Tresiba is a once-daily new-generation basal insulin analogue with a half-life of 25 hours and a duration of action of at least 42 hours.

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“Since 1923, Novo Nordisk has been committed to advancing insulin therapy for patients with diabetes, and we are proud to bring forward the first new basal insulin molecule to be approved by the FDA in 10 years,” explains Jesper Hiland, who is the president of Novo Nordisk in the U.S. as well as executive vice president of Novo Nordisk A/S. “Novo Nordisk is excited to launch Tresiba in the United States in the first quarter of 2016.”

The preliminary approval was based on the results of the BEGIN clinical trial, which also includes an interim analysis of DEVOTET. The results of the clinical trials showed that the drug could improve glycemic control.

“Managing blood sugar levels is a daily challenge for many people living with diabetes. This new treatment option will provide patients with a new way to help control their blood sugar,” said Dr Chris Sorli, Chairman in the Department of Diabetes, Endocrinology and Metabolism, as well as the Medical Director of Diabetes Services, at the Billings Clinic, Billings, MT.

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“After seeing the impact Tresiba has had on patients worldwide, we look forward to bringing it to those living with diabetes in the U.S. With its long-acting profile, Tresiba offers a new treatment option for adults living with diabetes who require a basal insulin,” said Dr Todd Hobbs, U.S. chief medical officer for Novo Nordisk.

Senior analyst for the brokerage firm Sydbank, Soren Lontoft Hansen, said, “The U.S. market for basal insulin represents over 80 percent of the global market. We expect a positive price reaction on Monday between 5 percent and 10 percent.”

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Source-Medindia