VOXZOGO

What it is

Voxzogo contains vosoritide , which is a modified type C natriuretic peptide (CNP) . Voxzogo is for subcutaneous injection . The medicine is available in three strengths: 0.4 mg, 0.56 mg, and 1.2 mg powder with diluent for injection .

Approved indications

— Treatment of achondroplasia in paediatric patients whose epiphyses are not closed .

Dosing overview

The volume of Voxzogo administered is based on the patient's weight and the vosoritide concentration, with single dose volumes ranging from 0.12 mL to 0.40 mL depending on body weight . Treatment should be stopped upon confirmation of no further growth potential, indicated by a growth velocity of less than 1.5 cm/year and closure of epiphyses . Patients should be monitored every 3 to 6 months to check body weight, growth and physical development, and dose should be adjusted according to body weight .

Key safety warnings

Patients with significant cardiac or vascular disease and patients on anti-hypertensive medications were excluded from premarketing clinical trials; to reduce the risk of a potential decrease in blood pressure and associated symptoms (dizziness, fatigue and/or nausea), patients should be well hydrated at the time of injection . Voxzogo has moderate influence on the ability to drive, cycle and use machines as it may cause transient decreases in blood pressure that are usually mild but syncope, pre-syncope, and dizziness have been reported; patients should be advised not to drive, cycle or use machines for at least 60 minutes after injection .

Contraindications

Hypersensitivity to the active substance or to any of the excipients is a contraindication .

PBS listing

All three strengths of Voxzogo powder for injection with diluent (0.4 mg, 0.56 mg, and 1.2 mg) are listed on the PBS with authority required restriction and an ex-manufacturer price of A$9226.00 per item .

Regulatory history

Voxzogo was first registered on the ARTG on 6 July 2022 across three strength variants . The PBAC initially did not recommend the medicine in July 2022, deferred consideration in September 2022, and recommended it in November 2022 for treatment of achondroplasia in patients whose epiphyses are not closed . The AusPAR approval date was 29 June 2022 .