Rymti, Etera
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 2018 |
| First round evaluation completed | 18 April 2019 |
| Sponsor provides responses on questions raised in first round evaluation | 18 June 2019 |
| Second round evaluation completed | 9 August 2019 |
| Delegate's overall benefit-risk assessment and request for Advisory Committee advice | 5 November 2019 |
| Sponsor's pre-Advisory Committee response | 18 November 2019 |
| Advisory Committee meeting | 6 December 2019 |
| Registration decision (Outcome) | 28 January 2020 |
| Completion of administrative activities and registration on ARTG | 1 October 2020 |
| Number of working days from submission dossier acceptance to registration decision* | 226 |
*Statutory timeframe for standard applications is 255 working days
Treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, plaque psoriasis or paediatric plaque psoriasis. Patients may self-inject only if their physician determines that it is appropriate and with medical follow-up, as necessary, after proper training in injection technique.
Patients treated with Rymti/Etera should be given the Patient Alert Card.
Dosage
Dosage is based on multiple factors, including the condition being treated and the age of the patient.
For further information, refer to the Product Information.
Rymti, Etera (etanercept) was approved for the following therapeutic use:
Rymti, Etera is indicated for the treatment of:
Adults
Rheumatoid arthritis
Active, adult rheumatoid arthritis (RA) in patients who have had inadequate response to one or more disease-modifying antirheumatic drugs (DMARDs). Rymti, Etera can be used in combination with methotrexate.
Severe, active rheumatoid arthritis in adults to slow progression of disease-associated structural damage in patients at high risk of erosive disease.
Psoriatic arthritis
The signs and symptoms of active and progressive psoriatic arthritis in adults, when the response to previous disease-modifying antirheumatic therapy has been inadequate. Etanercept has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function.
Plaque psoriasis
Adult patients with moderate to severe chronic plaque psoriasis, who are candidates for phototherapy or systemic therapy.
Ankylosing spondylitis
The signs and symptoms of active ankylosing spondylitis in adults.
Non-radiographic axial spondyloarthritis
Treatment of adults with active* non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or MRI change who have had an inadequate response to NSAIDs.
* Active disease is defined as a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of ≥ 4.
Children and adolescents
Children and adolescents weighing less than 62.5 kg should not receive Rymti, Etera. These patients should be accurately dosed on a mg/kg basis with other etanercept products.
Juvenile idiopathic arthritis
Active polyarthritis (rheumatoid factor positive or negative) in children and adolescents, aged 2 to 17 years, who have had an inadequate response to one or more DMARDs.
Active extended oligoarthritis in children and adolescents, aged 2 to 17 years, who have had an inadequate response to, or who have proved intolerant to, methotrexate.
Active enthesitis-related arthritis in adolescents, aged 12 to 17 years, who have had an inadequate response to, or who have proved intolerant to, conventional therapy.
Active psoriatic arthritis in adolescents, aged 12 to 17 years, who have had an inadequate response to, or who have proved intolerant to, methotrexate.
Etanercept has not been studied in children aged less than 2 years.
Paediatric plaque psoriasis
Chronic, severe plaque psoriasis in children and adolescents from 4 to 17 years, who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies. Duration of therapy to be no longer than 24 weeks and treatment to be ceased after 12 weeks if a significant Psoriasis Area and Severity Index (PASI) response is not achieved.
- The etanercept European Union (EU)-Risk Management Plan (RMP) (version 0.4, dated 20 June 2019, data lock point 29 May 2019), with Australian Specific Annex (version 0.3, dated 21 August 2019), included with submission PM-2018-03223-1-3, 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).
Reports are to be provided in line with the current published list of EU reference dates and frequency of submission of PSURs 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 (Rev 1), Part VII.B Structures and processes. Note that submission of a PSUR does not constitute an application to vary the registration.
- All batches of Rymti/Etera (etanercept) imported into/manufactured in Australia must comply with the product details and specifications approved during evaluation and detailed in the Certified Product Details (CPD).
The Certified Product Details (CPD), as described in Guidance 7: Certified Product Details of the Australian Regulatory Guidelines for Prescription Medicines (ARGPM), in PDF format, for the above products should be provided upon registration of these therapeutic goods. In addition, an updated CPD should be provided when changes to finished product specifications and test methods are approved in a Category 3 application or notified through a self-assessable change.
- Up to 5 initial batches of Rymti/Etera (etanercept) imported into/manufactured in Australia is not released for sale until samples and/or the manufacturer's release data have been assessed and endorsed for release by the TGA Laboratories Branch. Outcomes of laboratory testing are published biannually in the TGA Database of Laboratory Testing Results.
The sponsor should be prepared to provide product samples, reference materials and documentary evidence as defined by the TGA Laboratories branch. The sponsor must contact Biochemistry.Testing@health.gov.au for specific material requirements related to the batch release testing/assessment of the product. More information is available at TGA testing of biological medicines.
This batch release condition will be reviewed and may be modified on the basis of actual batch quality and consistency. This condition remains in place until the sponsor is notified in writing of any variation.
- The following clinical study report must be submitted to the TGA, as soon as possible after completion, for evaluation as Category 1 submission:
- Study CTRI/2019/01/016851
- For all injectable products the Product Information must be included with the product as a package insert.