Ascendis Receives Orphan Drug Exclusivity and Launches YUVIWEL® (Navepegritide) in the United States
Source: The Manila times
Published on: 2026-04-06 20:28
- YUVIWEL was granted orphan drug exclusivity by U.S. FDA to increase linear growth in pediatric patients 2 years of age and older with achondroplasia with open epiphyses - YUVIWEL is now commercially available in the U.S. with revenue now recognized following approval of first patients and initiation of therapy COPENHAGEN, Denmark, April 06, 2026 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced that YUVIWEL (navepegritide; developed as TransCon® CNP) was granted orphan drug exclusivity by the U.S. Food & Drug Administration (FDA) and that YUVIWEL is now commercially available in the United States. YUVIWEL is the first and only once-weekly treatment approved by FDA to increase linear growth in children 2 years of age and older with achondroplasia with open epiphyses and is the only one to provide continuous systemic exposure to CNP over the weekly dosing interval....
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