Ferring Pharmaceuticals said last week that the FDA approved its injectable somatropin product for four additional pediatric indications: idiopathic short stature, short stature associated with Turner syndrome, short stature born small for gestational age with no catch-up growth by 2 – 4 years and growth failure in short stature homeobox-containing gene deficiency.
In connection with the new approvals, Ferring plans to launch a needle-free drug-delivery system for its somatropin product in September this year.
The drug, known as Zomacton, was previously cleared by the FDA to treat growth failure in children caused by an inadequate production of endogenous growth hormone, as well as the replacement of endogenous growth hormone in adults with a deficiency.
Ferring noted that roughly 3-5% of children in the U.S. have short stature and many of the available treatments require using needles.
“Parents struggle to deliver their child’s daily dose of growth hormone due to children’s fear and anxiety of needles,” Teresa Tucker, co-founder & patient advocate at The Magic Foundation, said in prepared remarks. “Parents and patients will welcome an option that is completely needle free.”
“We are expanding the Ferring endocrinology portfolio with new indications and a delivery system to meet patient needs,” Paul Navarre, CEO of Ferring Holding, added. “Many patients object to needles, no matter how small. Ferring will now offer the only completely needle-free option for treating these diseases.”