Navepegritide
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| Trade names | Yuviwel |
| Other names | ACP-015 |
| AHFS/Drugs.com | Monograph |
| MedlinePlus | a626036 |
| License data | |
| Routes of administration | Subcutaneous injection |
| ATC code |
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| Legal status | |
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Navepegritide, sold under the brand name Yuviwel, is a medication used for the treatment of achondroplasia in children. Navepegritide is a C-type natriuretic peptide analog. It is given by subcutaneous injection.
Navepegritide was approved for medical use in the United States in March 2026.
Medical uses
Navepegritide is indicated to increase linear growth in children aged two years of age and older with achondroplasia (the most common form of dwarfism) with open epiphyses (growth plates).
Achondroplasia is a genetic condition that causes short stature and disproportionate growth. The average height of an adult with achondroplasia is approximately four feet. People with achondroplasia have a genetic mutation that causes a certain growth regulation gene called fibroblast growth factor receptor 3 to be overly active, which prevents normal bone growth. Achondroplasia occurs in approximately 1 in 10,000 to 1 in 30,000 live births per year.
History
The effectiveness of navepegritide was established in a clinical trial that included a randomized, placebo-controlled 52-week double-blind treatment period, followed by a single-arm 52-week open-label extension period (Trial 1; NCT05598320).
The trial enrolled 84 pediatric participants with genetically confirmed achondroplasia who had never received treatment: 57 participants received navepegritide 0.1 mg/kg administered subcutaneously (under the skin) once weekly, and 27 received a placebo.
Society and culture
Legal status
Navepegritide was approved for medical use in the United States in March 2026. The US Food and Drug Administration (FDA) granted the application for navepegritide priority review designation and accelerated approval.
In October 2026, the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Yuviwel, intended for the treatment of achondroplasia in children. The applicant for this medicinal product is Ascendis Pharma Growth Disorders.
Names
Navepegritide is the international nonproprietary name.
Navepegritide is sold under the brand name Yuviwel.
References
- 1 2 3 4 "Yuviwel- navepegritide kit". DailyMed. 25 March 2026. Retrieved 8 May 2026.
- ↑ Taylor-Miller T, Savarirayan R (November 2024). "Progress in managing children with achondroplasia". Expert Review of Endocrinology & Metabolism. 19 (6): 479–486. doi:10.1080/17446651.2024.2390416. PMID 39132812.
- 1 2 3 4 5 6 7 8 9 10 11 "FDA approves drug for pediatric patients with most common form of dwarfism". U.S. Food and Drug Administration (FDA) (Press release). 4 March 2026. Retrieved 6 April 2026.
This article incorporates text from this source, which is in the public domain. - ↑ "FDA Approves Once-Weekly Yuviwel (navepegritide) for Children with Achondroplasia Aged 2 Years and Older". Ascendis Pharma (Press release). 18 November 2021. Retrieved 6 April 2026.
- 1 2 "Yuviwel EPAR". European Medicines Agency (EMA). 16 October 2026. Retrieved 18 October 2026. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
- ↑ World Health Organization (2023). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 89". WHO Drug Information. 37 (1). hdl:10665/366661.
External links
- Clinical trial number NCT05598320 for "A Clinical Trial to Evaluate Efficacy and Safety of TransCon CNP Compared With Placebo in Children With Achondroplasia (ApproaCH)" at ClinicalTrials.gov
