January 29, 2021: Novo Nordisk announced today that the Committee for Medicinal Products for Human Use (CHMP), under the European Medicines Agency (EMA), adopted a positive opinion for the use of once-weekly Sogroya® (somapacitan), recommending marketing authorisation for the treatment of adults with growth hormone deficiency (AGHD).
The CHMP recommends once-weekly Sogroya® (somapacitan) to be indicated for the replacement of endogenous growth hormone in adults with AGHD.
Sogroya® (somapacitan) is a new long-acting human growth hormone therapy that is taken once a week by injection under the skin.
This recommendation is based on the results from REAL 1, a clinical trial programme investigating the efficacy and safety of Sogroya® (somapacitan) in adults with growth hormone deficiency.
“We are very pleased with the positive opinion for once-weekly Sogroya® as we are committed to continuously developing innovative and efficient medicines for people living with growth hormone deficiency,” said Mads Krogsgaard Thomsen, executive vice president and chief scientific officer of Novo Nordisk.
“We are confident that Sogroya® will make management of this serious chronic disease easier and help improve the quality of life for more people living with growth hormone deficiency.”
Another phase 3 trial, REAL 4, is ongoing, investigating the efficacy and safety of somapacitan in children living with growth hormone deficiency.
Sogroya® (somapacitan) for the treatment of adult growth hormone deficiency was approved by the US FDA on 28 August 2020 and the Ministry of Health, Labour and Welfare in Japan on 22 Jan 2021.
About Sogroya® (somapacitan)
Sogroya® (somapacitan) is a new long-acting human growth hormone therapy that is taken once a week by injection under the skin.
Somapacitan is produced with a small attachment that enables binding with the natural albumin within the body, extending the circulation time of somapacitan once injected.
The phase 3 trial REAL 1 investigated the efficacy and safety of somapacitan in a 34-week double-blind, placebo-controlled design, in 301 treatment-naïve adults with growth hormone deficiency.”
https://www.novonordisk.com/content/nncorp/global/en/news-and-media/news-and-ir-materials/news-details.html?id=44732
