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The Australian Prescription Medicine Decision Summary provides a short overview of the TGA's evaluation process leading to the registration of a new prescription medicine on the Australian Register of Therapeutic Goods (ARTG).
More in-depth information about the evaluation will be available in the Australian Public Assessment Report (AusPAR) for a particular prescription medicine, which can be found on the AusPAR search page once published.
Australian prescription medicine decision summary
|Submission type|| |
New chemical entity
|Product name|| |
|Active ingredients|| |
|ATC codes|| |
|Date of decision|| |
16 July 2020
|Date of entry onto ARTG|| |
17 July 2020
|ARTG numbers|| |
|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.
Celgene Pty Limited
|Sponsor address|| |
Level 15, 60 City Road, Southbank, VIC 3006
|Dose forms|| |
230 microgram and 460 microgram composite pack, 920 microgram
|Other ingredients|| |
Microcrystalline cellulose, silicon dioxide, croscarmellose sodium, and magnesium stearate
Gelatin, titanium dioxide, yellow iron oxide, black iron oxide and red iron oxide
TekPrint SW-9008 or TekPrint SW-9049
Blister wallet composite pack, blister
|Pack sizes|| |
Zeposia initiation pack: 7 capsules (4 x 230 microgram, 3 x 460 microgram)
Zeposia 920 microgram capsules: 28 capsules
|Routes of administration|| |
Treatment should be initiated under the supervision of a physician experienced in the management of multiple sclerosis (MS).
The recommended dose of Zeposia for adults is 920 microgram once daily taken orally.
The initial dose escalation regimen of Zeposia from Day 1 to Day 7 is shown below:
Days 1 to 4: 230 microgram once daily
Days 5 to 7: 460 microgram once daily
Days 8 and thereafter: 920 microgram once daily
Following the 7 day dose escalation, the maintenance dosage is 920 microgram once daily taken orally starting on Day 8. Initiation of Zeposia without dose escalation may result in greater reductions in heart rate (see Section 4.4).
For further information refer to the Product Information.
|Pregnancy category|| |
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.
Zeposia (ozanimod) was approved for the following therapeutic use:
Zeposia is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis.
Ozanimod is a sphingosine 1-phosphate (S1P) receptor modulator, which binds with a high affinity to sphingosine 1-phosphate receptor subtypes 1 (S1P1) and 5 (S1P5). Ozanimod causes lymphocyte retention in lymphoid tissues. The mechanism by which ozanimod exerts therapeutic effects in multiple sclerosis (MS) is unknown but may involve the reduction of lymphocyte migration into the central nervous system.
Ozanimod is 10 fold more selective for S1P1 relative to S1P5 and has little activity on other S1P receptors (S1P2, S1P3, and S1P4). Ozanimod is extensively metabolized in humans to form a number of circulating active metabolites. In vitro, ozanimod and its active metabolites demonstrated similar activity and selectivity for S1P1 and S1P5. In humans, approximately 94% of circulating total active drug exposure is represented by ozanimod (6%) and major human metabolites, CC112273 (73%), and CC1084037 (15%).
The following table summarises the key steps and dates for this application.
|Submission dossier accepted and first round evaluation commenced||31 July 2019|
|First round evaluation completed||27 February 2020|
|Sponsor provides responses on questions raised in first round evaluation||26 March 2020|
|Second round evaluation completed||15 April 2020|
|Delegate's overall benefit-risk assessment||1 July 2020|
|Sponsor's pre-Advisory Committee response||Not applicable|
|Advisory Committee meeting||Not applicable|
|Registration decision (Outcome)||16 July 2020|
|Completion of administrative activities and registration on ARTG||17 July 2020|
|Number of working days from submission dossier acceptance to registration decision*||218|
*Statutory timeframe for standard applications is 255 working days
- Zeposia (ozanimod) is to be included in the Black Triangle Scheme. The Product Information (PI) and Consumer Medicines Information (CMI) for Zeposia 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 ozanimod European Union (EU)-risk management plan (RMP) (version 1.0, dated 23 April 2020, data lock point 30 June 2018), with Australian specific Annex (version 1.0, dated 28 June 2019), included with submission PM-2019-02397-1-1, 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).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 (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.