Once a week under the skin injection growth hormone! Noor and Nord Sogroya are recommended by THECHMP

Novo Nordisk recently announced that the European Medicines Agency's (EMA) Commission on Human Pharmaceutical Products (CHMP) has issued an active review recommending the approval of the weekly long-acting growth hormone derivative Sogroya (somapacitan-beco) for the treatment of adult growth hormone deficiency (AGHD).
chMP's comments will now be submitted to the European Commission, which is expected to make a final review decision within two months.
Sogroya was approved by the U.S. Food and Drug Administration (FDA) on August 28, 2020 and by japan's Ministry of Health, Labour and Labor (MHLW) on January 22, 2021 for the treatment of adult growth hormone deficiency (AGHD).
sogroya is suitable for replacing endogenetic growth hormone in adult patients with AGHD.
it is worth noting that Sogroya is the first human growth hormone (hGH) therapy to treat adult GHD only once a week, while other approved hGH preparations must be injected daily.
the efficacy and safety of sogroya in treating adult patients with AGGH have been proven in the REAL 1 study.
is currently conducting another Phase 3 clinical trial, REAL 4, to assess Sogroya's efficacy and safety in children with growth hormone deficiency. Mads Krogsgaard Thomsen, executive vice president and chief scientific officer of
nono and Nord, said, "We are very pleased that the weekly long-acting growth hormone Sogroya receives a positive review from CHMP because we are committed to continuously developing innovative and efficient drugs for people with growth hormone deficiency.
believe that Sogroya will make the treatment of this serious chronic disease easier and help improve the quality of life of more people with growth hormone deficiency.
"Sogroya's active pharmaceutical ingredient is somapacitan, a long-acting human growth hormone (hGH) similar to protein technology that has been used for nearly 20 years to extend the half-life of insulin, GLP-1.
is modified by the natural hGH to enhance its binding to the plasma protein albumin, making it suitable for weekly dosing.
, somapacitan is being developed to treat growth hormone deficiency (GHD), both in adults and children.
The current availability of growth hormone drugs must be injected daily under the skin, which can be a considerable therapeutic burden for patients and their caregivers, and fatigue from years of daily injections can have a negative impact on adherence to treatment, leading to worse treatment results.
-acting treatment, which is available once a week, will represent a significant step forward in achieving better outcomes by increasing treatment compliance.
results showed that at the end of the 34-week treatment period, patients in the sogroya group who received weekly treatment had an average reduction of 1.06 percent in torso fat, while patients in the placebo group had a 0.47 percent increase in torso fat and a 2.23 percent reduction in torso fat in the Norditropin group once a day.
similar improvements at other clinical endpoints in patients in the Sogroya group once a week and in the Norditropin group once a day.
In this trial, the most common side effects of Sogroya included back pain, joint pain, indigestion, sleep disorders, dizziness, tonsillitis, swelling of the arms or calves, vomiting, adrenal insufficuation, high blood pressure, increased blood creatrophosphate kinase (an enzyme), weight gain, and anemia.
original source: Novo Nordisk receives positive opinion from the European regulatory authorities for once-weekly Sogroya® (somapacitan) for the treatment of adult growth food hormoney This article is sourced from Bio Valley, for more information please download Bio Valley APP (somapacitan)