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Oxervate
Sponsor
Device/Product name
Oxervate
Active Ingredient
Cenegermin (rbe)
Date of decision
Published
Submission type
New biological entity
ATC codes
S01XA24
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 Oxervate 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 |
|---|---|
| Positive designation for: Orphan | 23 May 2018 |
| Positive designation for: Priority review | 30 August 2018 |
| Submission dossier accepted and first round evaluation commenced | 31 October 2018 |
| Evaluation completed | 18 June 2019 |
| Delegate's overall benefit-risk assessment and request for Advisory Committee advice | 1 July 2019 |
| Sponsor's pre-Advisory Committee response | 17 July 2019 |
| Advisory Committee meeting | 1-2 August 2019 |
| Registration decision (Outcome) | 16 September 2019 |
| Completion of administrative activities and registration on ARTG | 1 October 2019 |
| Number of working days from submission dossier acceptance to registration decision* | 181 |
*Target timeframe for priority applications is 150 working days from acceptance for evaluation to the decision.
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
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.
Pregnancy category
Category B3Drugs 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 have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.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
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
Oxervate contains cenegermin, a recombinant form of human nerve growth factor.Nerve growth factor is an endogenous protein involved in the differentiation and maintenance of neurons, which acts through specific high-affinity (that is, tropomyosin receptor kinase A (TrkA)) and low-affinity (that is, p75 neurotrophin receptor (p75NTR)) nerve growth factor receptors located on the anterior surface of the eye. The treatment with cenegermin, administered as eye drops, is intended to allow restoration of corneal integrity.
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.