FDA Approves Somatropin Injection to Treat Growth Hormone Deficiency

The FDA has approved Zomacton, a somatropin injection, for the replacement of growth hormone in adults with GH deficiency.

Ferring announced that the Food and Drug Administration (FDA) has approved Zomacton (somatropin [rDNA origin]) injection for the replacement of growth hormone (GH) in adults with GH deficiency.

Zomacton is already indicated to treat pediatric patients who have growth failure due to inadequate secretion of endogenous GH.

Two studies of patients with adult-onset GH deficiency (n=98) and 2 studies of adults with childhood-onset GH deficiency (n=67) evaluated the effects of replacement therapy with another somatropin product. The primary efficacy measures were body composition and lipid parameters.

For patients with adult-onset GH deficiency, treatment with another somatropin product vs placebo led to an increase in mean lean body mass (2.59kg vs -0.22kg; <.001) as well as a reduction in body fat (-3.27kg vs 0.56kg; <.001).

The data were similar for adults with childhood-onset GH deficiency. Changes in lean body mass lasted throughout the 18-month period for both study populations.

In addition, low baseline HDL levels were normalized by the end of the treatment period with the somatropin product (mean change 13.7mg/dL [adult-onset] and 11.1mg/dL [childhood-onset]; <.001). 

Zomacton, a recombinant human GH, is available as 5mg and 10mg strength lyophilized powder for subcutaneous (SC) injection after reconstitution in vials. The Zoma-Jet needle free delivery device can also be used to administer the 5mg and 10mg doses.

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Ferring’s Zomacton® (somatropin) for injection receives FDA approval to treat growth hormone deficiency in adults [press release]. Parsippany, NJ; PRNewswire: January 31, 2018. Accessed February 5, 2018.

This article originally appeared on MPR