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Oxervate

9 October 2019

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

Product name
Oxervate
Active ingredients
Cenegermin (rbe)
ATC codes
S01XA24
Decision
Approved
Date of decision
16 September 2019
Date of entry onto ARTG
1 October 2019
ARTG numbers
310960
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
JACE Pharma Pty Ltd
Sponsor address
7 Clunies Ross Court, Eight Mile Plains QLD 4113
Dose forms
Eye drops, Solution
Strength
20 µg/mL
Other ingredients
Trehalose dehydrate; Mannitol; Dibasic sodium phosphate; Monobasic sodium phosphate dehydrate; Hypromellose; Macrogol 6000; Methionine; Water for injections; Hydrochloric acid; Sodium hydroxide; Nitrogen.
Containers
Vial
Pack sizes
7/carton
Routes of administration
Ophthalmic
Dosage

Adults: The recommended dose is one drop of Oxervate in the conjunctival sac of the affected eye(s), 6 times a day at 2 hourly intervals, starting from the morning and within 12 hours. Treatment should be continued for eight weeks.

For further information refer to the Product Information.

What was approved?

Oxervate (cenegermin (rbe)) was approved for the following therapeutic use:

Treatment of moderate (persistent epithelial defect) or severe (corneal ulcer) neurotrophic keratitis in adults.

This indication was given orphan designation and was accepted as a priority review (see Table under What steps were involved in the decision process, below).

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?

  • Oxervate cenegermin (rbe) is to be included in the Black Triangle Scheme. The PI and CMI for Oxervate 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 Oxervate cenegermin (rbe) EU-Risk Management Plan (EU-RMP), version 1.0, dated 16 May 2017 (data lock point 22 February 2017), with Australian Specific Annex (ASA), version 1.2, dated 30 August 2019, included with submission PM-2018-04728-1-5, 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 this 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.

  • The sponsor is required to provide the TGA with a copy of the proposed educational materials, including instructional video, for approval before the medicine is marketed.
  • The sponsor is required to update the ASA with the details of the educational program. This should include how health care providers, pharmacists and patients can access educational materials.
    • Batch release testing & compliance with Certified Product Details (CPD)
    • All batches of Oxervate imported into/manufactured in Australia must comply with the product details and specifications approved during evaluation and detailed in the Certified Product Details (CPD).
    • Each batch of Oxervate 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 on TGA testing of biological medicines is available at: Testing of biological medicines.

      This batch release condition will be reviewed and may be modified on the basis of actual batch quality and consistency.

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.