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On December 22, the website of the Drug Review Center (CDE) of China's State Drug Administration announced that Novo Nordisk's Class 1 bio-new drug somapacitan injections had been approved by clinical trials to treat children with slow growth due to insufficient endogenous growth hormone secretion.
was approved by the FDA at the end of August for adult patients with growth hormone deficiency (GHD), making it the first long-acting human growth hormone (hGH) treatment to be injected only once a week under the skin, according to public data released by
.
Screenshot Source: CDE's official website, Soomapacitan (Sogroya), is a novel, reversible human growth hormone derivative that binds to albumin and is modified by natural hGH to enhance its binding to endogenous plasma protein albumin, thus prolonging the half-life of molecules.
the addition of fatty acids to therapeutic proteins through acrylicization promotes the binding of these molecules to circulating albumin.
in humans, the non-co-price binding of molecules to albumin in the blood leads to reduced clearance rates and greatly prolongs half-life in the body.
public information, somapacitan has non-co-priced albumin binding properties of fatty acids, which makes it possible to give drugs once a week subsulvation.
, somapacitan had achieved positive results in a randomized, double-blind, placebo-controlled trial of 300 patients with growth hormone deficiency.
these patients had never received growth hormone therapy or stopped treatment with other growth hormone preparations for at least three months before the study and were randomly assigned weekly somapacitan, weekly placebo or daily growth hormone injections.
at the end of the 34-week treatment period, patients who took somapacitan weekly had an average torso fat content of 1.06 percent, compared with 0.47 percent in placebo and 2.23 percent in the daily growth hormone group.
similar improvements in other clinical endpoints in patients in the weekly somapacitan group and the daily growth hormone group.
fat is fat grown in the body's torso or middle, regulated by growth hormone, and may be associated with serious medical problems.
The Noro and Nordsomapacitan injections have been approved clinically in China to treat children who are slow to grow due to insufficient endogenous growth hormone secretion, meaning that this long-acting growth hormone is expected to benefit more children.
not only plays an important role in development from childhood to adulthood, but also contributes to the health of hormone balance.
childhood growth hormone deficiency is a serious rare disease caused by the pituitary glyphs not producing enough growth hormone.
children with GHD are not only short, but also experience metabolic abnormalities.
primary goal of GHD therapy in children is to normalize height in childhood, reach puberty in a timely manner and normal adolescent growth.
, however, for decades, the standard of care for children with GHD has been to inject human growth hormone once a day under the skin to improve growth and metabolism.
for caregivers and patients, the burden of daily injections is high, which can lead to poor compliance and lower overall treatment outcomes.
the properties of weekly injections of Noor and Nordsomapacitan, which are expected to greatly improve patient compliance.
References: China's State Drug Administration Drug Review Center. Retrieved Nov 27,2019, from FDA approves weekly therapy for adult growth hormone deficiency. Retrieved Sep1,2020, from T , Rasmussen M H , De Schepper J , et al. Somapacitan, a once‐weekly reversible albumin‐binding GH derivative, in children with GH deficiency: A randomized dose‐escalation trial[J]. Clinical Endocrinology, 2017.Source:Supplied