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FDA Medication Tracker

← All approvals · Rare & genetic · 2026

Yuviwel (navepegritide)

The FDA approved Yuviwel (navepegritide) on February 27, 2026 to increase linear growth in pediatric patients 2 years and older with achondroplasia with open epiphyses.
Brand name
Yuviwel
Generic name
navepegritide
FDA approval date
February 27, 2026
Approved use (FDA wording)
To increase linear growth in pediatric patients 2 years and older with achondroplasia with open epiphyses
Company
Ascendis
Application
NDA219164
Dosage form / route
POWDER · SUBCUTANEOUS
Boxed warning on label
Not listed
Category on this site
Rare & genetic

Indications and usage, from the FDA label

YUVIWEL ® is indicated to increase linear growth in pediatric patients 2 years of age and older with achondroplasia with open epiphyses. This indication is approved under accelerated approval based on an improvement in annualized growth velocity [see Clinical Studies (14) ]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). YUVIWEL is a C-type natriuretic peptide (CNP) analog indicated to increase linear growth in pediatric patients 2 years of age and older with achondroplasia with open epiphyses. ( 1 ) This indication is approved under accelerated approval based on an improvement in annualized growth velo…

Official sources

Facts only. This site lists what the FDA has approved and what the FDA says each drug is approved for, quoted or closely paraphrased from FDA and openFDA records. It gives no medical advice, no dosing, and no comparisons, and it says nothing about whether a drug is right for anyone. Talk to a licensed clinician about any medication. Records can lag or contain errors; the FDA's own pages are authoritative.