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Radicava
Sponsor
Device/Product name
Radicava
Active Ingredient
Edaravone
Date of decision
Published
Submission type
New chemical entity
ATC codes
N07XX14
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 Radicava 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 |
|---|---|
|
Designation (Orphan) |
17 August 2021 |
|
Submission dossier accepted and first round evaluation commenced |
1 November 2021 |
|
First round evaluation completed |
30 March 2022 |
|
Sponsor provides responses on questions raised in first round evaluation |
29 June 2022 |
|
Second round evaluation completed |
16 December 2022 |
|
Delegate’s Overall benefit-risk assessment and request for Advisory Committee advice |
31 October 2022 |
|
Sponsor’s pre-Advisory Committee response |
15 November 2022 |
|
Advisory Committee meeting |
1 December 2022 |
|
Registration decision (Outcome) |
17 January 2023 |
|
Completion of administrative activities and registration on ARTG |
15 February 2023 |
|
Number of working days from submission dossier acceptance to registration decision* |
192 |
*Statutory timeframe for standard applications is 255 working days
Date of entry onto ARTG
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
Concentrated injection
Strength
30 mg/20 mL
Other ingredients
Sodium bisulfite, cysteine hydrochloride monohydrate, sodium chloride, sodium hydroxide, phosphoric acid and water for injections.
Containers
Ampoule
Pack sizes
10
Routes of administration
Intravenous infusion
Dosage
The recommended dosage of Radicava is 60 mg of edaravone (two ampoules) diluted with 100 mL of 0.9% sodium chloride for infusion and administered as an intravenous infusion over a 60-minute period
For further information refer to the Product Information.
Pregnancy category
B3
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 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.
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 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
Radicava (edaravone) was approved for the following therapeutic use:
Radicava is indicated in adults with a diagnosis of amyotrophic lateral sclerosis who are independent in activities of daily living with normal respiratory function and where treatment is initiated within two years of disease onset.
Efficacy has not been demonstrated in patients outside of this defined population.
What is this medicine and how does it work
The mechanism by which Radicava exerts its therapeutic effect in patients with amyotrophic lateral sclerosis (ALS) is unknown. Edaravone is a free radical scavenger to reduce oxidative stress.
What post-market commitments will the sponsor undertake
- Radicava (edaravone) is to be included in the Black Triangle Scheme. The PI [Product Information] and CMI [Consumer Medicined Information] for Radicava 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 Radicava Core-Risk Management Plan (RMP) (version 1.1, dated 11 May 2021, data lock point 04 November 2017), with Australia Specific Annex (version 1.1, dated 26 May), included with submission PM-2021-04298-1-1, 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).
Unless agreed separately between the supplier who is the recipient of the approval and the TGA, the first report must be submitted to TGA no later than 15 calendar months after the date of the approval letter. The subsequent reports must be submitted no less frequently than annually from the date of the first submitted report until the period covered by such reports is not less than three years from the date of the approval letter. The annual submission may be made up of two PSURs each covering six months. If the sponsor wishes, the six-monthly reports may be submitted separately as they become available.
If the product is approved in the EU [European Union] during the three years period, reports can be provided in line with the published list of EU reference dates no less frequently than annually from the date of the first submitted report 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. Each report must have been prepared within ninety calendar days of the data lock point for that report.
- For all injectable products the Product Information must be included with the product as a package insert.