Camzyos
Registration timeline
The following table summarises the key steps and dates for this application.
|
Description |
Date |
|
Submission dossier accepted and first round evaluation commenced |
30 September 2021 |
|
First round evaluation completed |
29 March 2022 |
|
Sponsor provides responses on questions raised in first round evaluation |
30 May 2022 |
|
Second round evaluation completed |
2 August 2022 |
|
Delegate’s Overall benefit-risk assessment and request for Advisory Committee advice |
6 July 2022 |
|
Sponsor’s pre-Advisory Committee response |
20 July 2022 |
|
Advisory Committee meeting |
4 and 5 August 2022 |
|
Registration decision (Outcome) |
15 September 2022 |
|
Completion of administrative activities and registration on ARTG |
19 September 2022 |
|
Number of working days from submission dossier acceptance to registration decision* |
195 |
*Statutory timeframe for standard applications is 255 working days
Capsules: silicon dioxide, mannitol, hypromellose, croscarmellose sodium and magnesium stearate
Capsule shell: gelatin, titanium dioxide, black iron oxide, red iron oxide and yellow iron oxide
Printing ink: TekPrint SW-9008-N or SW-9009-N black ink
Treatment with mavacamten should be initiated and supervised by a specialist cardiologist, or consultant physician with experience in the management of obstructive hypertrophic cardiomyopathy (HCM).
Prior to initiating treatment with Camzyos, assess left ventricular ejection fraction (LVEF) by echocardiography. Treatment should not be initiated in patients with LVEF < 55%.
The recommended starting dose of Camzyos is 5 mg orally once daily.
It is important to regularly monitor the patient’s symptoms of obstructive HCM, left ventricular outflow tract gradient with Valsalva manoeuvre and LVEF using echocardiogram assessments. Patients who initiate or modify treatment with weak cytochrome P450 (CYP) 2C19 inhibitors or moderate CYP3A4 inhibitors, consider additional monitoring of LVEF and adjust dose based on clinical assessment (see Section 4.4 Special warnings and precautions for use of the Product Information).
For further information refer to the Product Information.
Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.
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.
Camzyos (mavacamten) was approved for the following therapeutic use:
Camzyos is indicated for the treatment of adults with symptomatic NYHA class II-III obstructive hypertrophic cardiomyopathy.
- Camzyos (mavacamten) is to be included in the Black Triangle Scheme. The PI [Product Information ] and CMI [Consumer Medicines Information] for Camzyos must include the black triangle symbol and mandatory accompanying text for five years, which starts from the date that the sponsor notifies the TGA of supply of the product.
- The Camzyos EU [European Union]-risk management plan (RMP) (version 1.0, dated 8 June 2021, data lock point 30 October 2020), with Australia specific annex (version 1.0, dated 20 August 2021), included with Submission PM-2021-03751-1-3, 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 the 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 the 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 the 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 (revision 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.