Novo Nordisk's Sogroya Receives EU Approval as First Once-Weekly Subcutaneous hGH Therapy for Adult Growth Hormone Deficiency

April 14, 2021 News /BioonBIOON/ -- According to the latest data from the European Union's new drug approval database, Novo Nordisk's long-acting growth hormone product Sogroya (somapacitan) has recently been approved by the European Commission (EC). The drug is administered via subcutaneous injection once weekly for the treatment of adult growth hormone deficiency (AGHD). According to information on the EC website, Sogroya holds 10 years of market exclusivity in the EU, effective from April 6, 2021, until its expiration on April 6, 2031.

Sogroya was approved by the U.S. Food and Drug Administration (FDA) in August 2020FDA) approval, and was approved by the Japanese Ministry of Health, Labour and Welfare (MHLW) in January 2021 for the treatment of adult growth hormone deficiency (AGHD). Sogroya is indicated for the replacement of endogenous growth hormone in patients with AGHD.

It is worth mentioning that,Sogroya is the first once-weekly subcutaneous injection human growth hormone (hGH) therapy for the treatment of adult GHD., while other approved hGH preparations require daily injections. The launch of Sogroya will make treatment easier and help improve patients' quality of life.

The efficacy and safety of Sogroya in the treatment of adult patients with AGHD have been demonstrated in the REAL 1 study. Currently, Novo Nordisk is conducting another Phase 3Clinical TrialsREAL 4, Evaluating the Efficacy and Safety of Sogroya in Pediatric Patients with Growth Hormone Deficiency.

Growth Hormone Deficiency (Image source: .patientpop.com)

Growth Hormone Deficiency (GHD) is a disorder characterized by insufficient secretion of growth hormone from the anterior pituitary gland, a small gland located at the base of the brain that produces multiple hormones. Growth hormone is a protein produced by the pituitary gland that regulates growth and metabolism. Adult patients with GHD may receive growth hormone as replacement therapy.

The active pharmaceutical ingredient of Sogroya is somapacitan, a long-acting analog of human growth hormone (hGH) that utilizes protein technology applied for nearly 20 years to extend the half-lives of insulin and GLP-1. Somapacitan is derived from natural hGH modified to enhance its binding to the plasma protein albumin, thereby enabling once-weekly dosing. Currently, somapacitan is under development for the treatment of growth hormone deficiency (GHD) in both adults and children.

Currently available growth hormone medications require daily subcutaneous injections, which can impose a significant treatment burden on patients and their caregivers. The fatigue associated with years of daily injections may negatively impact treatment adherence, thereby leading to poorer therapeutic outcomes. A once-weekly long-acting therapy would represent a major advance, enabling better treatment outcomes through improved adherence.

The efficacy and safety of Sogroya were evaluated in the randomized, double-blind, placebo-controlled Phase 3 study REAL 1. The trial enrolled 300 patients with growth hormone deficiency (GHD) who had either never received growth hormone therapy or had discontinued treatment with other growth hormone preparations for at least three months prior to the study. In the trial, patients were randomly assigned to receive once-weekly subcutaneous injections of Sogroya, once-weekly placebo (inactive treatment), or once-daily injections of Norditropin (somatropin, aFDAApproved growth hormone products (Novo Nordisk products). The efficacy of Sogroya was determined by the percentage change in trunk fat, which is fat accumulated in the body's trunk or central region, regulated by growth hormone and associated with serious medical conditions.

The results showed that at the end of the 34-week treatment period, patients receiving once-weekly Sogroya experienced a mean reduction in trunk fat of 1.06%, whereas patients in the placebo group had an increase of 0.47% and those in the once-daily Norditropin group had a reduction of 2.23%. Patients in the once-weekly Sogroya group and the once-daily Norditropin group also demonstrated similar improvements in other clinical endpoints.

In this trial, the most common side effects of Sogroya included: back pain, arthralgia, dyspepsia, sleep disorders, dizziness, tonsillitis, swelling of the arms or lower legs, vomiting, and adrenal insufficiency,Hypertension, elevated creatine phosphokinase (an enzyme), weight gain, andAnemia(Bioon.com)

Source: EU New Drug Approval Database