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Doptelet
Sponsor
Device/Product name
Doptelet
Active Ingredient
Avatrombopag maleate
Date of decision
Published
Submission type
New chemical entity
ATC codes
B02BX08
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 Doptelet 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 |
|---|---|
| Submission dossier accepted and first round evaluation commenced | 1 November 2021 |
| First round evaluation completed | 31 March 2022 |
| Sponsor provides responses on questions raised in first round evaluation | 30 May 2022 |
| Second round evaluation completed | 11 July 2022 |
| Delegate’s Overall benefit-risk assessment | 24 October 2022 |
| Sponsor’s pre-Advisory Committee response | Not applicable |
| Advisory Committee meeting | Not applicable |
| Registration decision (Outcome) | 13 January 2023 |
| Completion of administrative activities and registration on ARTG | 16 January 2023 |
| Number of working days from submission dossier acceptance to registration decision* | 247 |
*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
Tablet
Strength
20 mg
Other ingredients
Lactose monohydrate, colloidal anhydrous silica, crospovidone, magnesium stearate, microcrystalline cellulose and OPADRY II.
Containers
Blister pack
Pack sizes
10, 15 and 30
Routes of administration
Oral
Dosage
The recommended daily dose of Doptelet for patients with chronic liver disease is based on the patient’s platelet count prior to the scheduled procedure. Doptelet should be taken orally once daily for 5 consecutive days.
The recommended starting daily dose of Doptelet for patients with chronic immune thrombocytopenia is 20 mg once daily. Dose adjustments are based on the patient’s platelet count.
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
Doptelet (avatrombopag maleate) was approved for the following therapeutic use:
Doptelet is indicated for the treatment of thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure.
Doptelet is indicated for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.
What is this medicine and how does it work
Avatrombopag is an orally bioavailable, small molecule thrombopoietin (TPO) receptor agonist that stimulates proliferation and differentiation of megakaryocytes from bone marrow progenitor cells, resulting in an increased production of platelets. Avatrombopag does not compete with TPO for binding to the TPO receptor and has an additive effect with TPO on platelet production.
What post-market commitments will the sponsor undertake
- Doptelet (avatrombopag maleate) is to be included in the Black Triangle Scheme. The PI [Product Information] and CMI [Consumer Medicine Information] for Doptelet 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 Doptelet EU [European Union]-Risk Management Plan (RMP) (version 2.7, dated 10 December 2020; DLP [data lock point] 20 November 2020), with Australia Specific Annex (version 1.3, dated May 2022), included with submission PM-2021-04302-1-6, 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.
- Submit the final clinical study report for study AVA-ITP-401 (NCT04638829) for evaluation once completed.
- Submit the final clinical study report for study Sobi.Doptelet-001(NCT04943042) for evaluation once completed.