A positive EMA committee opinion positions somapacitan as the first growth hormone treatment recommended for ISS in the EU, pending European Commission sign-off.

Infarmed

Treatment provides option for children with growth failure

Novo Nordisk's long-acting injectable Sogroya has been backed for NHS use in young people with growth hormone deficiency

Novo Nordisk's long-acting growth hormone Sogroya works as well as Norditropin in a trio of paediatric growth disorders, with far fewer injections

New authorisation extends treatment to children with ISS, SGA and Noonan syndrome

Treatment provides option for children with growth failure

Novo Nordisk sought approval in April for Sogroya in three paediatric growth disorder indications.

What are the recent trends in market size and growth for the sogroya market? The sogroya market size has XX (HCAGR) in recent years. It will grow from $XX million in 2024 to $XX million in 2025 at a c...

Sogroya est un nouveau traitement substitutif pour les enfants de 3 ans et plus et les adultes ayant un déficit en hormone de croissance. Il s’agit d’un nouveau principe actif, le somapacitan ; grâce à sa longue durée d’action, Sogroya est administré une fois par semaine, soit une fréquence d’administration réduite par rapport à d’autres hormones de croissance disponibles en France. Sogroya est injecté par voie sous-cutanée.

Reported Friday, Feb 27 - 3:54pm EST (TheFly subscription required to read more.)

The FDA has approved Novo Nordisk's Sogroya®, a groundbreaking growth hormone therapy for various pediatric growth disorders, offering once-weekly convenience.

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...

This edition highlights major endocrinology developments, including Health Canada approval of Thyconvi, Korea reimbursement for Sogroya, FDA approval of levothyroxine tablets, and FDA Priority Review for Kerendia in type 1 diabetes and chronic kidney disease. Additional updates include Corcept’s relacorilant NDA resubmission plans, emerging AI-based osteoporosis screening research, FDA clearance of Control-IQ+ for pregnancy with type 1 diabetes, and new data showing Mounjaro’s advantages in early type 2 diabetes management.

This Endocrinology update highlights major developments across diabetes, hormone therapy, and endocrine disease management. Coverage includes European approval of Sandoz biosimilar insulins, Korea reimbursement access for Novo Nordisk’s Sogroya, ADA 2026 poster selections for Biomea’s icovamenib program, and new glucocorticoid-reduction guidance for CRENESSITY in classic CAH. Additional updates include diabetes gene therapy research from Genprex, the renaming of PCOS to PMOS, and an expanded diabetes data-management partnership between Glooko and mylife Diabetes Care.