Sogroya - opinion on variation to marketing authorisation

Opinion

EMA has issued an opinion on a change to this medicine's authorisation

somapacitan

Opinion

On 21 May 2026, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Sogroya. The marketing authorisation holder for this medicinal product is Novo Nordisk A/S.

The CHMP adopted two new indications as follows:

Sogroya is indicated for treatment of growth failure in children and adolescents in the following indications:

• Growth disturbance (current height SDS < -2.5 and parental adjusted height SDS < -1) in short children born small for gestational age (SGA), with a birth weight and/or length below -2 SD, who failed to show catch-up growth (HV SDS < 0 during the last year) by 4 years of age or later,
• Noonan syndrome (NS).

For information, the full indications for Sogroya will now be:

Paediatric patients

Sogroya is indicated for treatment of growth failure in children and adolescents in the following indications:

• The replacement of endogenous hormone (GH), aged 3 years and above due to growth hormone deficiency (paediatric GHD),
• Growth disturbance (current height SDS < -2.5 and parental adjusted height SDS < -1) in short children born small for gestational age (SGA), with a birth weight and/or length below -2 SD, who failed to show catch-up growth (HV SDS < 0 during the last year) by 4 years of age or later,
• Noonan syndrome (NS).

Adult patients

Sogroya is indicated for the replacement of endogenous growth hormone (GH) in adults with growth hormone deficiency (adult GHD).

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published on the EMA website in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.

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New text in bold.

CHMP post-authorisation summary of positive opinion for Sogroya (VR/0000264734)

Adopted Reference Number: EMADOC-1700519818-3170422

Key facts

• Name of medicine:
  Sogroya
• EMA product number:
  EMEA/H/C/005030
• Active substance:
  somapacitan
• International non-proprietary name (INN) or common name:
  somapacitan
• Therapeutic area (MeSH):
  Growth
• Anatomical therapeutical chemical (ATC) code:
  H01AC07
• Additional monitoring:

  This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

• Orphan:

  This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

• Marketing authorisation holder:
  Novo Nordisk A/S
• Date of opinion:
  21/05/2026
• Status:
  Positive