Xeris Pharmaceuticals, Inc., a specialty drug company , announced that the ecu Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive Opinion for Ogluo (glucagon). Ogluo is that the EU brand name for Xeris’ RTU glucagon for injection. The CHMP recommends Ogluo for the treatment of severe hypoglycaemia in adults, adolescents, and youngsters aged 2 years and over with DM .
The European Commission will review the CHMP recommendation, and a final judgment on the Marketing Authorization Application for Ogluo within the European Union (EU) is predicted within the half-moon of 2021. If Ogluo is approved, the corporate could launch Ogluo in certain European countries within the last half of 2021. Gvoke PFS and Gvoke HypoPen (glucagon injection) were approved within the US in 2019 for the treatment of pediatric and adult patients with diabetes over 2 years aged .
“The positive CHMP recommendation brings us one step closer to offering a replacement , simple and reliable treatment for patients in Europe who are at-risk for a severe hypoglycemic event,” said Paul R. Edick, chairman and CEO of Xeris. “We anticipate to the ecu Commission’s decision and therefore the opportunity to potentially change people’s ability to confidently answer a severe hypoglycemic event during a timely manner.”
The positive Opinion received yesterday is predicated on the results from a phase 3, multi-center, randomized controlled, non-inferiority study. The study was conducted among 132 adults with type 1 diabetes in Europe and North America to guage the liquid stable glucagon auto-injector as a treatment for severe hypoglycemic events compared with Novo Nordisk’s GlucaGen HypoKit. The results demonstrated comparable efficacy between the 2 groups in achieving a plasma glucose of >70 mg/dL or =20 mg/dL increase in plasma glucose concentration within half-hour of administration. The study also found that point to resolution of hypoglycemia symptoms also as time to resolution of the general feeling of hypoglycemia were comparable. No safety or tolerability concerns were noted. during this study, the foremost common adverse reactions were nausea and vomiting.
Xeris received US regulatory approval in 2019 for Gvoke (glucagon) injection, its ready-to-use, room-temperature stable liquid glucagon for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes ages 2 years and above. the corporate continues to guage additional applications to deal with needs in severe hypoglycemia and related conditions.
Xeris may be a specialty drug company delivering innovative solutions to simplify the experience of administering important therapies that folks believe a day round the world.