The Food and Drug Administration (FDA) has approved Zomacton (somatropin; Ferring) for the treatment of pediatric patients with idiopathic short stature (ISS), short stature associated with Turner syndrome, short stature born small for gestational age (SGA) with no catch-up growth by 2–4 years, and short stature or growth failure in short stature homeobox-containing gene (SHOX) deficiency.
Previously, the product was approved for growth failure in children due to inadequate endogenous growth hormone (GH) secretion and for the replacement of endogenous GH in adults with GH deficiency.
Ferring also announced plans to launch the ZOMA-Jet 10 Needle-Free Delivery System this September. Currently, Zomacton is supplied in 5mg and 10mg vials that require reconstitution prior to subcutaneous administration.
“We are expanding the Ferring endocrinology portfolio with new indications and a delivery system to meet patient needs,” said Paul Navarre, CEO, Ferring Holding Inc. (US). “Many patients object to needles, no matter how small. Ferring will now offer the only completely needle-free option for treating these diseases.”
For more information visit FerringUSA.com.