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Scenesse
Sponsor
Device/Product name
Scenesse
Active Ingredient
Afamelanotide acetate
Date of decision
Published
Submission type
New chemical entity
ATC codes
D02BB02
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 Scenesse 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, evaluated through Priority Review.
| Description | Date |
|---|---|
| Positive Designation - Priority | 23 October 2019 |
| Positive Designation - Orphan | 25 January 2019, extension 1 July 2019 |
| Submission dossier accepted and first round evaluation commenced | 31 January 2020 |
| Evaluation completed | 24 April 2020 |
| Delegate's overall benefit-risk assessment and request for Advisory Committee advice | 7 July 2020 |
| Sponsor's pre-Advisory Committee response | 20 July 2020 |
| Advisory Committee meeting | 7 August 2020 |
| Registration decision (Outcome) | 22 October 2020 |
| Completion of administrative activities and registration on ARTG | 18 November 2020 |
| Number of working days from submission dossier acceptance to registration decision* | 144 |
*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
Controlled release implant
Strength
16 mg afamelanotide (as 18 mg afamelanotide acetate)
Other ingredients
Polyglactin
Containers
Vial
Pack sizes
One
Routes of administration
Subcutaneous
Dosage
Scenesse should be administered by a healthcare professional. All healthcare professionals should be proficient in the subcutaneous implantation procedure and have completed the training program provided by Clinuvel prior to administration of the Scenesse implant.
A single Scenesse 16 mg implant is inserted subcutaneously above the anterior supra-iliac crest every 2 months.
For further information refer to the Product Information.
Pregnancy category
B1Drugs 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 not shown 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
Scenesse (afamelanotide) was approved for the following therapeutic use:
Scenesse is indicated for prevention of phototoxicity in adult patients with erythropoietic protoporphyria (EPP).
What is this medicine and how does it work
Afamelanotide is a synthetic tridecapeptide and a structural analogue of α-melanocyte stimulating hormone (α-MSH). Afamelanotide is a melanocortin receptor agonist and binds predominantly to the melanocortin-1 receptor (MC1-R). It acts with four fold greater potency than α-MSH in vitro and, due to increased resistance to proteolysis, has a longer duration of action in vivo.Activation of the MC1-R receptor by afamelanotide stimulates the synthesis of eumelanin in melanocytes.Eumelanin contributes to photoprotection through different mechanisms including: strong broadband absorption of ultraviolet (UV) and visible light, where eumelanin acts as a filter antioxidant activity through scavenging of free radicals; and inactivation of the superoxide anion and increased availability of superoxide dismutase to reduce oxidative stress.
What post-market commitments will the sponsor undertake
- Scenesse (afamelanotide) is to be included in the Black Triangle Scheme. The Product Information (PI) and Consumer Medicines Information (CMI) for Scenesse 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 Afamelanotide (Scenesse) EU-Risk Management Plan (RMP) (version 8.1, dated 1 February 2018, data lock point 22 June 2017), with Australian Specific Annex (version 1.4, dated April 2020), included with submission PM-2019-05977-1, 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.
- For all injectable products the PI must be included with the product as a package insert.