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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|| |
18 September 2020
|Date of entry onto ARTG|| |
23 September 2020
|Original publication date|| |
6 October 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
Maxx Pharma Pty Ltd
|Sponsor address|| |
Level 11, 500 Collins St, Melbourne VIC 3000
|Dose forms|| |
|Other ingredients|| |
Capsule content: lactose monohydrate, sodium starch glycollate type A, pregelatinised maize starch, magnesium stearate.
Capsule shell: gelatin, indigo carmine aluminium lake, erythrosine, titanium dioxide
Printing ink: shellac, titanium dioxide, propylene glycol, ammonia, simethicone.
|Pack sizes|| |
90, 30 and 10 capsules
|Routes of administration|| |
The recommended dose of opicapone is 50 mg. Ongentys should be taken once daily at bedtime, preferably without food, at least one hour before or after levodopa combinations.
For further information refer to the Product Information.
|Pregnancy category|| |
Drugs 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 are inadequate or may be lacking, but available data show no 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.
Ongentys (opicapone) was approved for the following therapeutic use:
Ongentys is indicated as adjunctive therapy to preparations of levodopa/DOPA decarboxylase inhibitors (DDCI) in adult patients with Parkinson's disease and end-of-dose motor fluctuations who cannot be stabilised on those combinations.
Opicapone is a peripheral, selective and reversible catechol-O-methyltransferase (COMT) inhibitor endowed with a high binding affinity (sub-picomolar) that translates into a slow complex dissociation rate constant and a long duration of action (> 24 hours) in vivo.
In the presence of a DOPA decarboxylase inhibitor (DDCI), COMT becomes the major metabolising enzyme for levodopa, catalysing its conversion to 3-O-methyldopa (3-OMD) in the brain and periphery. In patients taking levodopa and a peripheral DDCI, such as carbidopa or benserazide, opicapone increases levodopa plasma levels thereby improving the clinical response to levodopa.
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 Ongentys was considered favourable for the therapeutic use approved.
The following table summarises the key steps and dates for this application.
|Submission dossier accepted and first round evaluation commenced||10 September 2019|
|First round evaluation completed||23 March 2020|
|Sponsor provides responses on questions raised in first round evaluation||11 May 2020|
|Second round evaluation completed||18 June 2020|
|Delegate's overall benefit-risk assessment and request for Advisory Committee advice||2 July 2020|
|Sponsor's pre-Advisory Committee response||23 July 2020|
|Advisory Committee meeting||6 and 7 August 2020|
|Registration decision (Outcome)||18 September 2020|
|Completion of administrative activities and registration on ARTG||23 September 2020|
|Number of working days from submission dossier acceptance to registration decision*||222|
*Statutory timeframe for standard applications is 255 working days
- Ongentys (opicapone) is to be included in the Black Triangle Scheme. The Product Information (PI) and Consumer Medicines Information (CMI) for Ongentys 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 Ongentys European Union (EU)-Risk Management Plan (RMP) (version 3.0, dated 15 October 2015, data lock point 30 April 2015), with Australian Specific Annex (version 3.0, dated 29 June 2020), included with submission PM-2019-03218-1-1, 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.