phase 2 confirmatory study

Established safety

in adults and children1,2

Established safety in adults and children1

No relevant safety differences in type of adverse events were observed in 8 clinical studies compared with other approved GBCAs during Phase II and Phase III clinical studies on VUEWAY® (gadopiclenol):†

†Compared to Gadovist® (gadobutrol) and MultiHance® (gadobenate dimeglumine).3,5-7

The entire clinical development program included 1047 subjects exposed to gadopiclenol: 967 adults, 80 pediatric patients (2 years and older).1 Adults were exposed to doses ranging from 0.025 to 0.3 mmol/kg; pediatric patients to 0.05 mmol/kg.

 

VUEWAY® at 0.05 mmol/kg is well tolerated in patients aged 2 to 17 years.2

Prospective, multicenter, open-label study: 80 patients in three sequential groups by age: 12-17, 7-11, and 2-6 years.

Most common AEs for VUEWAY® were headache and injection-site pain (most AEs mild in intensity).1

No differences related to age, sex, race1

 

No effects on QT interval / ventricular repolarization4

References

 

1 VUEWAY® (gadopiclenol) SmPC, EMA, 10/2023.

2 Jurkiewicz E, Tsvetkova S, Grinberg A, et al. Pharmacokinetics, Safety, and Efficacy of Vueway (Gadopiclenol) in Pediatric Patients Aged 2 to 17 Years, Investigative Radiology: March 21, 2022 - Volume - Issue - doi: 10.1097/RLI.0000000000000865.

3 Bendszus M, Roberts D, Kolumban B, et al. Dose Finding Study of Vueway (Gadopiclenol), a New Macrocyclic Contrast Agent, in MRI of Central Nervous System. Invest Radiol. 2020 Mar;55(3):129-137.

4 GADOVIST® (gadobutrol) SmPC, 07/2022.

5 MultiHance® (gadobenate dimeglumine) injection, 529 mg/mL Full Prescribing Information and Patient Medication Guide. Monroe Twp., NJ: Bracco Diagnostics Inc.; August 2018.

6 Loevner LA, Kolumban B, Hutóczki G, et al. Efficacy and safety of gadopiclenol for contrast-enhanced MRI of the central nervous system: the PICTURE randomized clinical trial. Invest Radiol. 2023 May;58(5):307-313.

7 Funck-Brentano C, Felices M, Le Fur N, et al. Randomized study of the effect of Vueway (Gadopiclenol), a new gadolinium-based contrast agent, on the QTc interval in healthy subjects. Br J Clin Pharmacol 2020; 86:2174-2181.