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Vocabria
Published
Product name
Vocabria
Active ingredient
Cabotegravir (as sodium)
Submission type
New chemical entity
Decision
Approved
Decision date
Registration date
What this medicine was approved for
Vocabria (cabotegravir) was approved for the following therapeutic use:
Vocabria tablets are indicated in combination with rilpivirine tablets for the short-term treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults who are virologically suppressed (HIV-1 RNA <50 copies/mL) and have no known or suspected resistance to either cabotegravir or rilpivirine (see Sections 4.2 Dose and Method of Administration and 5.1 Pharmacodynamic Properties, Clinical Trials) for:
- oral lead in to assess tolerability of cabotegravir prior to administration of cabotegravir prolonged-release suspension for injection plus rilpivirine prolonged-release suspension for injection.
- oral therapy for adults who will miss planned dosing with cabotegravir prolonged-release suspension for injection.
How this medicine works
Cabotegravir inhibits human immunodeficiency virus type 1 (HIV) integrase by binding to the integrase active site and blocking the strand transfer step of retroviral deoxyribonucleic acid (DNA) integration which is essential for the HIV replication cycle.
Why the TGA approved or did not approve this medicine
The decision was based on quality (chemistry and manufacturing), nonclinical (pharmacology and toxicology), clinical (pharmacology, safety and efficacy) and risk management plan information submitted by the sponsor. The benefit-risk profile of Vocabria was considered favourable for the therapeutic use approved.
Sponsor