The Priority Review

Approvals Brief

CHMP adopts positive opinion on Yuviwel for achondroplasia

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion on 15 October 2026, recommending marketing authorisation for Yuviwel (navepegritide) for children 2 years and older with achondroplasia. The opinion notes that Yuviwel improves annualised growth velocity by 1.49 cm versus placebo in a 52-week trial.

Primary source

EMA medicine page (CHMP opinion), October 16, 2026

Yuviwel (Navepegritide): EMA CHMP opinion

Read the source: Yuviwel (Navepegritide): EMA CHMP opinion ema.europa.eu

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