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Vocabria
Sponsor
Device/Product name
Vocabria
Active Ingredient
Cabotegravir (as sodium)
Date of decision
Published
Submission type
New chemical entity
ATC codes
J05AJ04
Decision
Approved
What was the decision based on
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.
What steps were involved in the decision process
Registration timeline
The following table summarises the key steps and dates for this application.
| Description | Date |
|---|---|
| Submission dossier accepted and first round evaluation commenced | 31 October 2019 |
| First round evaluation completed | 31 March 2020 |
| Sponsor provides responses on questions raised in first round evaluation | 10 July 2020 |
| Second round evaluation completed | 11 September 2020 |
| Delegate's overall benefit-risk assessment and request for Advisory Committee advice | 3 November 2020 |
| Sponsor's pre-Advisory Committee response | 18 November 2020 |
| Advisory Committee meeting | 3 and 4 December 2020 |
| Registration decision (Outcome) | 10 February 2021 |
| Completion of administrative activities and registration on ARTG | 16 February 2021 |
| Number of working days from submission dossier acceptance to registration decision* | 253 |
*Statutory timeframe for standard applications is 255 working days
Date of entry onto ARTG
Original publication date
Black triangle scheme
Yes. This product will remain in the scheme for 5 years, starting on the date the product is first supplied in Australia.
Dose forms
Tablet, film coated
Strength
30 mg
Other ingredients
Lactose monohydrate, microcrystalline cellulose, hypromellose, sodium starch glycolate type A, magnesium stearate, titanium dioxide and macrogol.
Containers
Bottle
Pack sizes
30
Routes of administration
Oral
Dosage
Vocabria should be prescribed by a physician experienced in the management of human immunodeficiency virus (HIV) infection.
Vocabria is indicated for the treatment of HIV-1 in combination with rilpivirine, therefore, the product information for rilpivirine should be consulted for recommended dosing.
Adults
Oral lead-in dosing
Vocabria tablets are recommended for approximately one month (at least 28 days) in virologically suppressed patients prior to the initiation of cabotegravir injections, a component of Cabenuva (cabotegravir and rilpivirine prolonged release suspensions for injection), to assess tolerability to cabotegravir. One Vocabria tablet (30 mg) should be taken with one rilpivirine tablet (25 mg) once daily.
The final oral dose should be taken on the same day injections with Cabenuva are started.
Elderly
No dose adjustment is required in elderly patients. There are limited data available on the use of cabotegravir in patients aged 65 years and over (see Section 5.2 Pharmacokinetic Properties, Special Patient Populations in the Product Information).
For further information refer to the Product Information.
Pregnancy category
B1Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed.Studies in animals have not shown evidence of an increased occurrence of fetal damage.The use of any medicine during pregnancy requires careful consideration of both risks and benefits by the treating health professional. This must not be used as the sole basis of decision making in the use of medicines during pregnancy. The TGA does not provide advice on the use of medicines in pregnancy for specific cases. More information is available from obstetric drug information services in your State or Territory.
What was approved
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.
What is this medicine and how does it work
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.
What post-market commitments will the sponsor undertake
- Vocabria (cabotegravir) is to be included in the Black Triangle Scheme. The Product Information (PI) and Consumer Medicines Information (CMI) for Vocabria must include the black triangle symbol and mandatory accompanying text for five years, which starts from the date that the sponsor notifies the Therapeutic Goods Administration (TGA) of supply of the product.
- The Vocabria European Union (EU)-Risk Management Plan (RMP) (version 0.3, dated 7 August 2020, data lock point 6 June 2019), with Australian specific annex (version 1.2, dated 26 August 2020), included with submission PM-2019-04281-1-2, and any subsequent revisions, as agreed with the TGA will be implemented in Australia.
An obligatory component of risk management plans is routine pharmacovigilance. Routine pharmacovigilance includes the submission of periodic safety update reports (PSURs).
Unless agreed separately between the supplier who is the recipient of the approval and the TGA, the first report must be submitted to TGA no later than 15 calendar months after the date of this approval letter. The subsequent reports must be submitted no less frequently than annually from the date of the first submitted report until the period covered by such reports is not less than three years from the date of this approval letter. The annual submission may be made up of two PSURs each covering six months. If the sponsor wishes, the six monthly reports may be submitted separately as they become available.
If the product is approved in the EU during the three years period, reports can be provided in line with the published list of EU reference dates no less frequently than annually from the date of the first submitted report until the period covered by such reports is not less than three years from the date of this approval letter.
The reports are to at least meet the requirements for PSURs as described in the European Medicines Agency's Guideline on Good Pharmacovigilance Practices (GVP) Module VII-periodic safety update report (Rev 1), Part VII.B Structures and processes. Note that submission of a PSUR does not constitute an application to vary the registration. Each report must have been prepared within ninety calendar days of the data lock point for that report.