US EditionFDA Approves Novo Nordisk's Sogroya® as the First and only Once-Weekly, Long-Acting Growth Hormone for Three Additional Pediatric Indications
The FDA approved once-weekly Sogroya for pediatric growth conditions, offering an alternative to daily injections and reducing treatment burden, supported by REAL8 study data.
- Today, the U.S. Food and Drug Administration approved three pediatric indications for Sogroya, including children aged 2.5 years and older with growth failure.
- Data from the REAL8 study showed once-weekly somapacitan-beco was noninferior to daily growth hormone for height velocity at 1 year in children aged 2.5 years and older.
- The drug is given once weekly via subcutaneous injection, and Aristides Maniatis, MD, said it offers '313 injection-free days per year'.
- Previously, Sogroya held approvals for adults and certain pediatric uses, building on decades of daily injections defining the treatment paradigm, according to the company.
- Novo Nordisk said in a press release that the FDA approved three new pediatric uses for Sogroya, highlighting its once-weekly dosing as an effective care option for families and clinicians.
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27 Articles
LoudounTimes.com
FDA approves Novo Nordisk's Sogroya® as the first and only once-weekly, long-acting growth hormone for three additional pediatric indications
New indications expand treatment options for appropriate children aged 2.5 years and older with Idiopathic Short Stature (ISS), born Small for Gestational Age (SGA), or Noonan Syndrome (NS)1Sogroya® (somapacitan-beco) is a once-weekly treatment option, offering an alternative to once-daily therapy,…
FDA approves three new pediatric indications for once-weekly growth hormone injection
The FDA has approved three new pediatric indications for somapacitan-beco, a once-weekly, long-acting growth hormone injection, according to a press release issued by Novo Nordisk.Somapacitan-beco (Sogroya, Novo Nordisk) is now approved for children aged 2.5 years and older with idiopathic short stature, short stature born small for gestational age and no catch-up growth by age 2, and growth
FDA approves Novo Nordisk’s Sogroya® as the first and only once-weekly, long-acting growth hormone for three additional pediatric indications
New indications expand treatment options for appropriate children aged 2.5 years and older with Idiopathic Short Stature (ISS), born Small for Gestational Age (SGA), or Noonan Syndrome (NS)1 Sogroya® (somapacitan-beco) is a once-weekly treatment option, offering an alternative to once-daily therapy, which may help address the common challenge of non-adherence associated with daily injections2 These FDA approvals build on decades of treatment inn…
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