FDA Approves Sogroya (somapacitan-beco) by Novo Nordisk: First Once-Weekly Subcutaneous Growth Hormone Therapy for Adult Growth Hormone Deficiency

September 02, 2020 News /Bio ValleyBIOON/ -- The U.S. Food and Drug Administration (FDA) has recently approved Novo Nordisk's once-weekly long-acting growth hormone derivative, Sogroya (somapacitan-beco), for the treatment of growth hormone deficiency (GHD) in adults. Notably, in the treatment of adult GHD,Sogroya is the first human growth hormone (hGH) therapy requiring only once-weekly subcutaneous injection, while other approvedFDAApproved hGH preparations must be injected daily.

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 which has been applied to extend the half-lives of insulin and GLP-1 for nearly 20 years. 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 results through improved adherence.

Sogroya was evaluated in a randomized, double-blind, placebo-controlled trial. 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 in the once-weekly Sogroya group had a mean reduction in trunk fat of 1.06%, whereas those 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, joint pain, indigestion, sleep disorders, dizziness, tonsillitis, swelling of the arms or lower legs, vomiting, and adrenal insufficiency.Hypertension, increased blood creatine phosphokinase (an enzyme), weight gain, andAnemia。(Bioon.com)

Original Source:FDA approves weekly therapy for adult growth hormone deficiency