Novo Nordisk Files for FDA Approval of New Insulin

A brand new insulin will soon be on pharmacy shelves in the United States if Danish pharmaceutical company Novo Nordisk has its way. The company has filed for approval from the Food and Drug Administration to sell insulin degludec, an original formulation that lasts an extra-long time.

Insulin degludec is injected only once a day. Once under the skin, the dose of insulin is absorbed slowly and consistently, allowing for better nighttime control, according to Novo. Most importantly, test subjects had a low rate of hypoglycemia on the drug.

“We are very excited about being able to file for the approval of insulin degludec and insulin degludec/insulin aspart now also in the US,” said Novo Executive Vice President and Chief Science Officer Mads Krogsgaard Thomsen. “This is another significant milestone for Novo Nordisk and for the millions of people with diabetes who require insulin.”

As Thomsen mentioned, the company is also applying for approval of a dual formulation of insulin degludec and insulin aspart. In this combination, the long-lasting degludec is accompanied by the short-term aspart. An injection would therefore offer both 24-hour control and a needed bolus after a meal.

Extensive clinical trials have been undertaken to test the safety and efficacy of insulin degludec. The BEGIN and BOOST studies, which wrapped up last year, included nearly 10,000 people with type 1 or type 2 diabetes. Results from the studies showed that the insulin was indeed effective as a 24-hour treatment.

Novo Nordisk, which has a global reach, has spent nearly 90 years in the diabetes care field. Some of its best-known products include Levemir and NovoLog. Novo has also branched into hemophilia care, hormone replacement therapy, and growth hormone therapy.


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