Novo Nordisk diabetes treatments Tresiba and Ryzodeg approved by FDA
Two new drug treatments from Novo Nordisk that improve blood glucose control in adults have been approved by the US Food and Drug Administration (FDA).
Tresiba (insulin degludec injection) and Ryzodeg 70/30 (insulin degludec/insulin aspart injection) are long-acting insulins – they were both been approved following positive results of recent trials.
Tresiba is the brand name insulin degludec, a long-acting analogue insulin which acts for at least 42 hours. It is injected subcutaneously once daily.
A trial investigating the safety and efficacy of Tresiba involved 1,102 patients receiving the drug in combination with mealtime insulin. A separate study, meanwhile, evaluated Tresiba in 2,702 patients with type 2 diabetes.
Tresiba treatment led to reduced HbA1c levels in type 1 and type 2 patients who had poor control of blood glucose levels at the outset.
Ryzodeg 70/30 contains insulin degludec, but also insulin aspart, a rapid-acting human insulin analogue. Ryzodeg is injected once or twice a day with any main meal.
Ryzodeg 70/30 was assessed on 362 patients with type 1 diabetes over a 26-week trial, and on 998 type 2 diabetes patients. The findings were similar to the trial involving Tresiba: Ryzodeg 70/30 improved HbA1c levels amongst type 1 and type 2 patients with inadequate glycemic control.
The FDA noted that neither of the drugs are suitable for people who have increased levels of ketones in their blood or urine.
Lars Rebien Sorensen, president and chief executive officer of Novo Nordisk, said: “We are very happy with FDA’s decision to approve Tresiba(R) and Ryzodeg(R) 70/30 as we believe these products offer significant benefits and important treatment options for people with type 1 and type 2 diabetes.
“The approvals mark an important milestone for Novo Nordisk and we look forward to making Tresiba(R) available for people in the US”.
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