FDA Approves New Indications for Zomacton

Ferring Pharmaceuticals the U.S. Food and Drug Administration (FDA) has approved Zomacton (somatropin) for injection in four additional pediatric indications:

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 to 4 years

Short stature or growth failure in short stature homeobox-containing gene (SHOX) deficiency

Zomacton was previously approved to treat growth failure in pediatric patients due to inadequate secretion of endogenous growth hormone (GH) and replacement of endogenous GH in adults with GH deficiency. Along with these approvals, Ferring announced plans to launch the ZOMA-Jet 10 Needle-Free Delivery System for Zomacton in September.

It is estimated that around 3-5% of children in the United States have short stature, defined as a height below the 3rd percentile. Patients with short stature typically present with below average height in relation to their age, sex, racial group, or family. Currently, the majority of treatments for these diseases involve needles. However, in a recent study, over 60% of children ages 6-17 expressed a fear of needles.

"Parents struggle to deliver their child’s daily dose of growth hormone due to children’s fear and anxiety of needles," said Teresa Tucker, Co-Founder and Patient Advocate of The MAGIC Foundation. "Parents and patients will welcome an option that is completely needle free."

From September, Zomacton will be available to use with the ZOMA-Jet 10 Needle-Free Delivery System. ZOMA-Jet 10 will provide the only completely needle-free delivery option available for children being treated with growth hormone.

Zomacton is available by prescription in the U.S., offering both 5 and 10 milligram (mg) options. Ferring developed Zomacton and currently markets it in 47 countries globally.

"We are expanding the Ferring endocrinology portfolio with new indications and a delivery system to meet patient needs," said Paul Navarre, CEO, Ferring. "Many patients object to needles, no matter how small. Ferring will now offer the only completely needle-free option for treating these diseases."

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