FDA approves supplemental new drug application for Xeris

Xeris Pharmaceuticals announced today that the FDA approved its supplemental new drug application for the Gvoke kit.

Chicago-based Xeris’ Gvoke (Ogluo in Europe) a ready-to-use pre-mixed, pre-measured glucagon injection for treating severe hypoglycemia for people with diabetes ages 2 and above.

The kit will be available as a 1 mg/0.2 mL single dose vial and syringe kit with the approval of its sNDA by the FDA. The kit contains one single-dose sterile syringe with markings for o.1 mL (0.5 mg pediatric dose) and 0.2 mL (1 mg adult dose), and one single-dose vial containing 0.2 mL of solution, according to a news release.

On the back of the sNDA approval, Xeris said it plans to begin the scale-up of its manufacturing immediately, with the expectation that the Gvoke kit will be made available early in the first quarter of 2022.

Xeris recently entered into a $71 million licensing agreement for Gvoke (Ogluo in Europe) with Tetris Pharma, then earlier this month announced a milestone achievement for the payor coverage of Gvoke.

“Offering three different administration options – Gvoke HypoPen, Gvoke PFS, and Gvoke kit, allows for greater patient choice in a ready-to-use rescue product for the approximately 6.8 million people in the U.S. who rely on insulin and are at-risk of a severe hypoglycemic event. These innovative formats provide the reliability of a ready-to-use liquid glucagon while offering multiple administration options for patients and caregivers,” Xeris chairman & CEO Paul R. Edick said in the release. “In particular for patients or caregivers who prefer to draw up their Gvoke rescue dose using a vial and syringe, Gvoke kit reduces the number of steps by eliminating reconstitution – the most common mistake in correctly administering the conventional glucagon kit.” MassDevice