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Ponvory
Sponsor
ARTGs
370319 and 370320
370319 and 370320
Device/Product name
Ponvory
Active Ingredient
Ponesimod
Date of decision
Published
Submission type
New chemical entity
ATC codes
L04AA50
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 Ponvory 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 | 26 July 2021 |
| First round evaluation completed | 18 October 2021 |
| Sponsor provides responses on questions raised in first round evaluation | 5 January 2022 |
| Second round evaluation completed | 10 February 2022 |
| Delegate's overall benefit-risk assessment | 10 February 2022 |
| Sponsor's pre-Advisory Committee response | Not applicable |
| Advisory Committee meeting | Not applicable |
| Registration decision (Outcome) | 7 March 2022 |
| Completion of administrative activities and registration on ARTG | 11 March 2022 |
| Number of working days from submission dossier acceptance to registration decision* | 112 |
*The COR-A process has a 120 working day evaluation and decision timeframe
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
Film coated tablet
Strength
2 mg, 3 mg, 4 mg, 5 mg, 6 mg, 7 mg, 8 mg, 9 mg, 10 mg and 20 mg
Other ingredients
Croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, colloidal anhydrous silica, sodium lauryl sulfate, hypromellose, macrogol 3350, titanium dioxide, triacetin, iron oxide yellow (3 mg, 5 mg, 7 mg, 9 mg, 10 mg, 20 mg), iron oxide black (4 mg, 5 mg, 8 mg, 9 mg), iron oxide red (3 mg, 4 mg, 7 mg, 8 mg, 9 mg, 10 mg)
Containers
Composite blister pack (treatment initiation pack) and blister pack (treatment maintenance pack)
Pack sizes
Treatment initiation pack: 14 (2 x 2 mg, 2 x 3 mg, 2 x 4 mg, 1 x 5 mg, 1 x 6 mg, 1 x 7 mg, 1 x 8 mg, 1 x 9 mg, and 3 x 10 mg)Treatment maintenance pack: 28 (20 mg)
Routes of administration
Oral
Dosage
Treatment should be initiated under the supervision of a physician experienced in the management of multiple sclerosis. Multiple tests are required prior to starting treatment.
A treatment initiation pack must be used for patients starting treatment with Ponvory. Initiate Ponvory treatment following a 14 day titration schedule, with a starting dose of one 2 mg tablet orally. Progress with the titration schedule outlined in Product Information.
After dose titration schedule is complete, the recommended maintenance dosage of Ponvory is one 20 mg tablet taken orally once daily.
For further information refer to the Product Information.
Pregnancy category
DDrugs 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.
What was approved
Ponvory (ponesimod) was approved for the following therapeutic use:
Ponvory is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS) with active disease defined by clinical or imaging features.
What is this medicine and how does it work
Ponesimod is a sphingosine 1 phosphate (S1P) receptor 1 modulator. Ponesimod binds with high affinity to S1P receptor 1, which is expressed on a range of cell types including lymphocytes.Ponesimod blocks the capacity of lymphocytes to egress from lymph nodes reducing the number of lymphocytes in peripheral blood. The mechanism by which ponesimod exerts therapeutic effects in multiple sclerosis may involve reduction of lymphocyte migration into the central nervous system.
What post-market commitments will the sponsor undertake
- Ponvory (ponesimod) is to be included in the Black Triangle Scheme. The Product Information (PI) and Consumer Medicines Information (CMI) for Ponvory 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 Ponvory European Union (EU) risk management plan (RMP) (version 1.5, dated 25 May 2021, data lock point 18 March 2020), with Australian specific annex (version 3.0, dated 27 January 2022), included with Submission PM 2021 02609 1 1, to be revised to the satisfaction of 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 (revision 1), Part VII.B structures and processes. Note that submission of a PSUR does not constitute an application to vary the registration.