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FDA Approves Novo Nordisk's Sogroya for New Pediatric Uses

Key highlights
  • FDA approved Sogroya for three new pediatric indications.
  • Sogroya is a long-acting growth hormone administered weekly.
  • It is indicated for children with ISS, SGA, or NS.
  • Sogroya offers an alternative to daily growth hormone injections.

FDA Approval

The FDA has approved three new pediatric indications for Sogroya, a long-acting growth hormone developed by Novo Nordisk. This approval expands treatment options for children aged 2.5 years and older.

Indications

Sogroya is now indicated for children with Idiopathic Short Stature (ISS), those born Small for Gestational Age (SGA) without catch-up growth by age 2, and those with growth failure associated with Noonan Syndrome (NS).

Administration

Sogroya is administered once weekly, providing an alternative to the traditional daily injections. This may help improve adherence among patients who struggle with daily treatment regimens.

Existing Indications

In addition to the new pediatric indications, Sogroya is also approved for children and adults with growth hormone deficiency (GHD).