Yuviwel

Opinion

EMA has issued an opinion on this medicine

Navepegritide

Overview

On 15 October 2026, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Yuviwel, intended for the treatment of achondroplasia in children.

The applicant for this medicinal product is Ascendis Pharma Growth Disorders A/S.

Yuviwel will be available as 1.3 mg, 2.8 mg and 5.5 mg powder and solvent for solution for injection. The active substance of Yuviwel is navepegritide, a prodrug containing C-type natriuretic peptide (CNP), for treatment of bone diseases (ATC code: M05BD02). CNP released from navepegritide binds to the natriuretic peptide receptor B (NPR‑B) throughout the body and promotes chondrocyte differentiation and proliferation, thus stimulating bone growth.

The benefit of Yuviwel is that it improves the annualised growth velocity (AGV) by 1.49 cm compared to placebo, as shown in a randomised, double-blind, placebo‑controlled, 52‑week trial. The most common side effects are injection site reactions and hypertrichosis (abnormal hair growth, including at the injection site).

The full indication is:

Yuviwel is indicated for the treatment of achondroplasia in children 2 years of age and older whose epiphyses are not closed. The diagnosis of achondroplasia should be confirmed by appropriate genetic testing.

Yuviwel should be prescribed and treatment should be monitored by physicians experienced in the diagnosis and management of children with achondroplasia.

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

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Note: This product was designated as an orphan medicine during its development. EMA will now review the information available to date to determine if the orphan designation can be maintained

CHMP summary of positive opinion for Yuviwel

Adopted Reference Number: EMADOC-1829012207-76106

Product details

• Name of medicine:
  Yuviwel
• Active substance:
  navepegritide
• International non-proprietary name (INN) or common name:
  Navepegritide
• Therapeutic area (MeSH):
  Achondroplasia
• Anatomical therapeutic chemical (ATC) code:
  M05BX
• EMA product number:
  EMEA/H/C/006627
• 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 applicant:
  Ascendis Pharma Growth Disorders A/S
• Opinion adopted:
  15/10/2026
• Opinion status:
  Positive