FDA Approves Diabetes Drugs

The FDA today approved two new diabetes drugs. The agency gave the nod to insulin degludec injection (Tresiba/Novo Nordisk) and insulin degludec/insulin aspart (Ryzodeg/Novo Nordisk)

The US Food and Drug Administration today approved two new diabetes drugs.

The agency gave the nod to insulin degludec injection (Tresiba/Novo Nordisk) and insulin degludec/insulin aspart (Ryzodeg 70/30/Novo Nordisk) both of which are injections to to improve blood sugar control.

Tresiba is a long-acting insulin analog for adults with type 1 and type 2 diabetes. It is administered once daily at any time of day.

Ryzodeg is a mixture of insulin degludec and insulin aspart, a rapid-acting human insulin analog.

Neither should be used in patients who have high levels of ketones in their blood or urine.

As with all insulin analogs, these medications may cause hypoglycemia. Common adverse reactions also include allergic reactions, edema, and weight gain.

The agency had rejected the drugs two years ago citing concerns over cardiovascular safety, but a new clinical trial produced reassuring evidence.