March 22, 2021

The U.S. FDA has approved Zegalogue® (dasiglucagon), manufactured by Zealand Pharmaceuticals, to treat severe hypoglycemia (low blood sugar) in patients who have diabetes and are at least six years old.

Severe hypoglycemia is a drop in blood sugar that requires assistance from another person to treat and can be a complication of diabetes medications such as insulin. Early symptoms of low blood sugar include an irregular or fast heartbeat, fatigue, paleness, and feeling hungry, shaky, anxious, and/or irritable. As hypoglycemia worsens, it can cause confusion and abnormal behavior, blurred vision, seizures, and/or loss of consciousness. Treatment requires quickly raising blood sugar levels closer to normal with medication and/or high-sugar food or drinks. In worst case scenarios, hypoglycemia can lead to coma, brain damage, and death.

In clinical studies, patients who received Zegalogue had a median time to blood sugar recovery of 10 minutes compared to 30-45 minutes for patients given a placebo. In one study, 99% of patients given Zegalogue recovered within 15 minutes.

Recommended dosing is 0.6mg administered via subcutaneous injection with a single-dose prefilled syringe or autoinjector. The drug can be administered by the patient or a caregiver trained in proper injection technique. Emergency assistance should be sought immediately after administering Zegalogue. If there has been no response after 15 minutes, an additional 0.6mg dose from a new device can be administered while waiting for emergency aid. Once the patient has responded to treatment, they should receive oral carbohydrates.

Zealand Pharmaceuticals has not yet announced launch or pricing information.

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