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Novo Nordisk announced today that the European Medicines Agency's (EMA) Human Medicines Board (CHMP) has taken a positive approach to the weekly Sogroya® and recommended approval for the market for the treatment of adult patients with growth hormone deficiency (AGHD).
CHMP recommends weekly sogroya ® (somapacitan) in place of adult AGHD endogenetic growth hormone.
Sogroya ® is a new long-acting human growth hormone therapy that is injected under the skin once a week.
recommendation is based on the results of the REAL 1 trial.
REAL 1 is a clinical trial program to study the efficacy and safety ® somapacitan in adult AGHD patients.
phase III trial, REAL 4, is being studied for the efficacy and safety of Sogroya ® in patients with AGHD.
Sogroya ® (somapacitan), which is used to treat adult growth hormone deficiency, was approved by the U.S. Food and Drug Administration (FDA) on August 28, 2020 and japan's Ministry of Health, Labour and Industry on August 22, 2021.
