Business

Ascendis Receives Orphan Drug Exclusivity and Launches YUVIWEL® (Navepegritide) in the United States

- 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 dru

articleAscendis Pharma A/sApril 6, 20268/company/ascendis-pharma-as/news/ascendis-receives-orphan-drug-exclusivity-and-launches-yuviwelr-navepegritide-in-the-united-states
Ascendis Receives Orphan Drug Exclusivity and Launches YUVIWEL® (Navepegritide) in the United States

About this update from Ascendis Pharma A/s

[{"type":"image","alt":"Ascendis Pharma","displaySize":"","headline":null,"caption":"Ascendis Pharma","className":"","disableSlideshowImg":false,"size":{"original":{"width":300,"height":100,"url":"https://media.zenfs.com/en/globenewswire.com/7afd0e29f0a4b40bcd5ff718a81f4afe"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/CrOiU6PjkichWByBf44j0Q--/YXBwaWQ9aGlnaGxhbmRlcjt3PTQyMDtoPTE0MA--/https://media.zenfs.com/en/globenewswire.com/7afd0e29f0a4b40bcd5ff718a81f4afe","width":300,"height":100}},"lazy":false},{"type":"text","content":"- 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","length":170,"tagName":"p"},{"type":"text","content":"- YUVIWEL is now commercially available in the U.S. with revenue now recognized following approval of first patients and initiation of therapy","length":142,"tagName":"p"},{"type":"text","content":"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.","length":588,"tagName":"p"},{"type":"text","content":"Multiple YUVIWEL prescriptions have already been approved for reimbursement for children in the U.S. enrolled through the Ascendis Signature Access Program® (A.S.A.P.), with revenue now recognized following approval of first patients and initiation of therapy. Ascendis has established A.S.A.P. to provide support to children in the U.S. prescribed YUVIWEL and their caregivers throughout the treatment journey, including a dedicated Patient Access Liaison, programs designed to help navigate each step of the treatment process, and information about co-pay and other assistance programs for eligible patients. The program also provides resources for healthcare providers, including clinical education and assistance with prior authorization and appeals. Information about the A.S.A.P. pr...

More updates from Ascendis Pharma A/s

Ascendis Pharmaorphan drughealthcare providerYUVIWELachondroplasiaU.S. Food & Drug AdministrationFDAlinear growthside effectsTransConUnited States