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Ongentys

6 October 2020

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

Summary of submission

Submission type
New chemical entity
Product name
Ongentys
Active ingredients
Opicapone
ATC codes
N04BX04
Decision
Approved
Date of decision
18 September 2020
Date of entry onto ARTG
23 September 2020
Original publication date
6 October 2020
ARTG numbers
321017
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
Sponsor
Maxx Pharma Pty Ltd
Sponsor address
Level 11, 500 Collins St, Melbourne VIC 3000
Dose forms
Hard capsule
Strength
50 mg
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.

Containers
Blister pack
Pack sizes
90, 30 and 10 capsules
Routes of administration
Oral
Dosage

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

B2

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.

What was approved?

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.

What is this medicine and how does it work?

What was the decision based on?

What steps were involved in the decision process?

What post-market commitments will the sponsor undertake?

  • 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.

Further information

The latest Product Information (PI) and Consumer Medicines Information (CMI) can be found at: ARTG search.

Australian Public Assessment Reports (AusPARs) can be found at: AusPAR search.

The latest news and updates regarding therapeutic goods regulation can be found at: TGA news room.