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Relfydess (relabotulinumtoxinA, purified Botulinum toxin type A)
Australian Prescription Medicine Decision Summary
Published
Product name
Relfydess
Active ingredient
relabotulinumtoxinA, purified Botulinum toxin type A
Submission type
Type A (New chemical entity)
Decision
Approved
Registration date
What this medicine was approved for
Relfydess (relabotulinumtoxinA, purified Botulinum toxin type A) has been approved for the temporary improvement in the appearance of moderate to severe glabellar lines at maximum frown and moderate to severe lateral canthal lines seen at maximum smile.
How this medicine works
Both glabellar lines ("frown lines") and lateral canthal lines ("crows feet") are caused by repeated contractions in the muscles surrounding these regions which over time may result in permanent wrinkles. Relfydess (Clostridium botulinum type A neurotoxin) prevents the release of the neurotransmitter acetylcholine from nerve cells. When injected intramuscularly, acetylcholine inhibition by Relfydess induces partial paralysis of the affected muscle. This temporarily reduces muscle activity, leading to the transient reduction of glabellar lines or lateral canthal lines. Botulinum toxin type A products have a long duration of action, measured in weeks to months.
Why the TGA approved or did not approve this medicine
The approval was based on quality (chemistry and manufacturing), nonclinical (pharmacology and toxicology), clinical (pharmacology, safety and efficacy) and risk management plan data submitted by the sponsor.
The Relfydess clinical development program for moderate-to-severe GL and LCL included 6 studies:
- a Phase I dose-ranging study with GL and LCL treatment
- a Phase II dose-ranging study with GL treatment
- 3 pivotal Phase III double-blind, placebo-controlled studies (1 with GL only treatment, 1 with LCL only treatment, 1 with treatment in both GL and LCL regions), and
- a long-term, open-label safety study with multiple treatments in the GL and LCL regions.
Consumer Medicine Information (CMI)
The CMI leaflet offers guidance for consumers to support safe and effective use of the medicine. The CMI includes information on dose, how to use the medicine properly, potential side effects, safety precautions, storage instructions and more.
The Australian CMIs can be accessed through the ARTG details hyperlinks below.
Product Information (PI)
The PI document provides essential prescribing information for health professionals, including details on dosage recommendations, pregnancy category, contraindications, precautions and potential side effects.
The Australian PIs can be accessed through the ARTG details hyperlinks below.
Sponsor
Other resources
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For data and reports on health and welfare topics in Australia refer to the Australian Institute of Health and Welfare website.