Fast-acting Insulin, Fiasp, Gets FDA Approval
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Recently, the U.S. Food and Drug Administration approved Novo Nordisk’s latest fast-acting insulin, Fiasp, for treatment use by adults with diabetes. The move makes available a product that should allow those with type1 diabetes (T1D) to better meet their target A1C levels by controlling post-meal blood sugar spikes.
Fiasp, which is a fast-acting insulin aspart, is designed for dosing at the start of a meal or within 20 minutes of beginning to eat. The insulin registers in the blood stream as quickly as two and a half minutes after application.
“Generally individuals are well controlled in long insulin,” said Dr. Todd Hobbs, Novo Nordisk’s chief medical officer for North America. “But being able to hold down and keep the meal excursions from rising is going to have an effect on A1C. When individuals get close to their A1C goals—hit seven or eight—but can’t quite get over the hump, most of the time the barrier is meals.”
Fiasp grew out of the company’s previous fast-acting insulin product, NovoLog. With Fiasp the company improved the speed of initial insulin absorption rates by adding niacinamide (vitamin B3).
“With Fiasp we’ve built on the insulin aspart molecule to create a new treatment option to help patients meet their post-meal blood sugar target,” said Dr. Bruce Bode, president of Atlanta Diabetes Associates and an associate professor at Emory University School of Medicine.
Insulin aspart is a synthetic insulin manufactured from human insulin. A single amino acid is changed in the insulin’s chemical composition to help the insulin be absorbed into the body more quickly.
The traditional knock against fast-acting insulin is that’s it’s also fast going, wearing off quickly as well. With Fiasp, Novo Nordisk believes it can continue counteracting that stereotype.
“This is not a fast-on, fast-off insulin like inhaled insulin can be,” said Hobbs. “We’re basically shifting the effort of the insulin up front, in those first 30 minutes. It stays around almost as long as NovoLog, nearly four hours. If we can prevent blood sugars from rising quickly after the meal, we know there’s a much more stable period in the hours after meal.”
More than 2,000 adults with type 1 and type 2 diabetes were involved in the clinical trials that secured the drug’s approval. During trials, Fiasp was administered both at mealtime and after starting a meal. Trial data showed a consistent reduction in A1C in adults with type 1 and type 2.
Considered a new delivery for insulin, Fiasp had to go through the FDA process for adult approval first. Novo Nordisk has a standard pediatric plan in place and is in the process of securing youth approval.
Fiasp will launch at the same list price as NovoLog and be available by the end of the year in U.S. pharmacies. It will be packaged in a pre-filled delivery device, the FlexTouch pen, and a 10 mL vial.
The company said Fiasp is not yet approved for insulin pump use in the United States or Canada, though longer-term trial data towards that use is planned. It is approved for use in insulin pumps in several European Union member states.