Navepegritide
| Clinical data | |
|---|---|
| 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 | |
| Legal status | |
| Identifiers | |
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Navepegritide, sold under the brand name Yuviwel, is a medication used for the treatment of achondroplasia in children.[1][2] Navepegritide is a C-type natriuretic peptide analog.[1] It is given by subcutaneous injection.[1]
Navepegritide was approved for medical use in the United States in March 2026.[3]
Medical uses
[edit]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).[3]
Achondroplasia is a genetic condition that causes short stature and disproportionate growth.[3] The average height of an adult with achondroplasia is approximately four feet.[3] 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.[3] Achondroplasia occurs in approximately 1 in 10,000 to 1 in 30,000 live births per year.[3]
History
[edit]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).[3]
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.[3]
Society and culture
[edit]Legal status
[edit]Navepegritide was approved for medical use in the United States in March 2026.[3][4] The US Food and Drug Administration (FDA) granted the application for navepegritide priority review designation and accelerated approval.[3]
Names
[edit]Navepegritide is the international nonproprietary name.[5]
Navepegritide is sold under the brand name Yuviwel.[3]
References
[edit]- 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.
- ↑ 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
[edit]- 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
