The US Food and Drug Administration (FDA) has approved somapacitan (Sogroya) for the replacement of endogenous growth hormone in adults with growth hormone deficiency (GHD), according to a press release.
This is the first human growth hormone (hGH) therapy taken weekly by injection.
Approval was based off a randomized, double-blind, placebo-controlled trial of 300 patients with GHD randomly assigned to receive injections of weekly Sogroya, weekly placebo (inactive treatment), or daily somatropin. Effectiveness of treatment was determined by the percentage change of truncal fat.
At 34-weeks, truncal fat decreased by an average 1.06% in patients taking Sogroya.
Read the full press release here.