Diacomit
Registration timeline
The following table summarises the key steps and dates for this application.
| Description | Date |
|---|---|
| Submission dossier accepted and first round evaluation commenced | 31 October 2016 |
| First round evaluation completed | 26 April 2017 |
| Sponsor provides responses on questions raised in first round evaluation | 27 May 2017 |
| Second round evaluation completed | 21 August 2017 |
| Delegate's overall benefit-risk assessment and request for Advisory Committee advice | 2 July 2019 |
| Sponsor's pre-Advisory Committee response | 16 July 2019 |
| Advisory Committee meeting | 1-2 August 2019 |
| Registration decision (Outcome) | 11 September 2019 |
| Completion of administrative activities and registration on ARTG | 13 September 2019 |
| Number of working days from submission dossier acceptance to registration decision* | 242 |
*Statutory timeframe for standard applications is 255 working days
In capsules: Povidone; Sodium starch glycolate type A; Magnesium stearate; Gelatin; Titanium dioxide; Erythrosine (Diacomit 250 mg only); Indigotin carmine (Diacomit 250 mg only).
In powder for oral suspension: Aspartame; Spray-dried glucose syrup; Povidone; Sodium starch glycolate type A; Erythrosine; Titanium dioxide; Carmellose sodium; Hyetellose; Arome Polv Tutti Frutti 25 H 245 flavour (PI: 111164).
The dose of stiripentol is calculated on a mg/kg body weight basis. It is recommended to split the daily dose in two or three daily intakes (totalling the daily recommended dose per kg and per day). The initiation of adjunctive therapy with stiripentol should be undertaken gradually using upwards dose escalation to reach the recommended dose of 50 mg/kg/day.
Stiripentol dosage escalation should be gradual, starting with 20 mg/kg/day for 1 week, then 30 mg/kg/day for 1 week. Further dosage escalation is age dependent: - children less than 6 years should receive an additional 20 mg/kg/day in the third week, thus achieving the recommended dose of 50 mg/kg/day in three weeks; - children from 6 to less than 12 years should receive an additional 10 mg/kg/day each week, thus achieving the recommended dose of 50 mg/kg/day in four weeks; - children and adolescents 12 years and older should receive an additional 5 mg/kg/day each week until the optimum dose is reached based on clinical judgment.
For further information refer to the Product Information.
Diacomit (stiripentol) was approved for the following therapeutic use:
Diacomit is indicated for adjunctive treatment of generalised tonic-clonic and clonic seizures associated with severe myoclonic epilepsy in infancy (SMEI, also known as Dravet syndrome) in patients whose seizures are not adequately controlled with a benzodiazepine (usually clobazam) and valproate.
The following specific conditions of registration apply to this approval:
- The Diacomit EU-Risk Management Plan (RMP) (version 3.0, dated 9 June 2017, data lock point 18 August 2016), with Australian Specific Annex (version 0.1, dated October 2016), included with submission PM-2016-02336-1-1, to be revised to the satisfaction of the TGA, will be implemented in Australia.
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 (Rev1) Part VII.B Structures and processes. Not that submission of a PSUR does not constitute an application to vary the registration.
- Diacomit is to be included in the Black Triangle Scheme. The PI and CMI for Diacomit 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.