FDA

Yuviwel

Approved 27 Feb 2026SubcutaneousPowder

The FDA lists this product in 3 strengths and forms.

Indications

YUVIWEL ® is indicated to increase linear growth in pediatric patients 2 years of age and older with achondroplasia with open epiphyses. This indication is approved under accelerated approval based on an improvement in annualized growth velocity [see Clinical Studies (14) ]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). YUVIWEL is a C-type natriuretic peptide (CNP) analog indicated to increase linear growth in pediatric patients 2 years of age and older with achondroplasia with open epiphyses.

( 1 ) This indication is approved under accelerated approval based on an improvement in annualized growth velocity . Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). ( 1 )

Contraindications

None. None. ( 4 )

Warnings and precautions

Risk of Low Blood Pressure : Transient decreases in blood pressure have been reported with a once daily CNP analog. Advise patients to contact their healthcare provider if they experience symptoms of decreased blood pressure while being treated with YUVIWEL. ( 5.1 )

5.1Risk of Low Blood Pressure

Transient decreases in blood pressure have been reported with a once daily CNP analog. Subjects with hemodynamically significant cardiovascular disease were excluded from participation in navepegritide clinical trials. Advise patients to contact their healthcare provider if they experience symptoms of decreased blood pressure (e.g., dizziness, fatigue and/or nausea) while being treated with YUVIWEL.

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary

There are no available data on the use of YUVIWEL in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal reproduction studies, subcutaneous administration of navepegritide during the period of organogenesis in pregnant rats and rabbits resulted in no impact on embryo-fetal survival or congenital malformations at doses up to 10- and 7-fold, respectively, the exposure at the maximum recommended human dose (MRHD) (see Data ) .

At a glance

Brand name: Yuviwel
Active substance: navepegritide
Route: Subcutaneous
Dosage form: Powder
Applicant: Ascendis
Status: Prescription
FDA approval: 27 Feb 2026
Application: NDA219164-002

Indications

Warnings and precautions

5.1Risk of Low Blood Pressure

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary

Adverse reactions

Most common adverse reactions (≥ 5%): vomiting, injection-site reaction, pain in extremity, and nausea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Ascendis Pharma at 1-844-442-7236 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of YUVIWEL was evaluated in pediatric patients with achondroplasia in two randomized, placebo-controlled trials of navepegritide. Trial 1 included a 52-week, randomized, double-blind, placebo-controlled period, followed by a 52-week, single-arm, open-label extension (OLE) period.

In Trial 1, 84 pediatric participants with achondroplasia (mean age 5.7 years; range: 2 to 12 years) were randomized to subcutaneous navepegritide 0.1 mg/kg/week (n = 57) or placebo (n = 27) [see Clinical Studies (14) ] . Trial 2 included a randomized, double-blind, placebo-controlled dose-finding period. In Trial 2, 57 pediatric participants with achondroplasia (mean age 5.9 years; range: 2 to 10 years) were randomized 3:1 to subcutaneous navepegritide 0.006, 0.02, 0.05, or 0.1 mg/kg or placebo for 52 weeks.

At Week 52, all participants transitioned to an OLE period during which they received navepegritide 0.1 mg/kg/week for 104 weeks. The adverse reaction rates for navepegritide were derived from pediatric participants with achondroplasia who received navepegritide 0.1 mg/kg/week or placebo during the double-blind period of Trials 1 and 2. Of the dosages evaluated in Trials 1 and 2, 0.1 mg/kg/week is most similar to the approved weight-based dosage listed in Table 1.

Adverse reactions reported in the placebo-controlled pooled periods of Trials 1 and 2 in ≥ 5% of navepegritide-treated patients and at an incidence at least 2% greater than with placebo are presented in Table 2. Table 2: Adverse Reactions Reported in ≥ 5% of Participants Treated with Navepegritide 0.1 mg/kg/week and ≥ 2% Higher Than Placebo During the Placebo-Controlled Period of Trials 1 and 2 Adverse Reaction NAVEPEGRITIDE 0.1 mg /kg/week N = 68 n (%) Placebo N = 42 n (%) Vomiting 14 (21) 6 (14) Injection-site reaction Includes injection-site swelling, injection-site erythema, injection-site bruising, injection-site reaction, injection-site pruritus, injection-site discoloration, injection-site hemorrhage, injection-site pain, injection-site vesicles, and injection-site edema . 13 (19) 6 (14) Pain in extremity 8 (12) 3 (7) Nausea 4 (6) 0 Injection-Site Reactions During the 52-week double-blind period of Trials 1 and 2, 13 of 68 (19%) participants receiving navepegritide 0.1 mg/kg/week experienced a total of 25 events of injection-site reactions, while 6 of 42 (14%) participants receiving placebo experienced a total of 6 events of injection site reactions, corresponding to 0.4 events per person year exposure and 0.2 events per person year exposure, respectively.

Other Adverse Reactions from Trials 1 and 2 (Pooled) Hypertrichosis Hypertrichosis was reported in 2 of 68 patients (3%) receiving navepegritide 0.1 mg/kg/week compared to none receiving placebo in the double-blind periods of Trials 1 and 2. Cases presented as localized hair growth at injection sites or generalized increased body hair growth affecting limbs, back, or shoulders. To reduce the risk of local skin changes, rotate the site of injection with each dose.

Yuviwel

Indications

Contraindications

Warnings and precautions

5.1Risk of Low Blood Pressure

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary

At a glance

Two medicines in one question?

Yuviwel

Indications

Contraindications

Warnings and precautions

5.1Risk of Low Blood Pressure

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary

At a glance

Two medicines in one question?

Adverse reactions

6.1Clinical Trials Experience

Composition

Strengths and forms

Official product information