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Bimzelx
ARTGs
353268 and 353269
353268 and 353269
Device/Product name
Bimzelx
Active Ingredient
Bimekizumab
Date of decision
Published
Submission type
New biological entity
ATC codes
L04AC21
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 Bimzelx 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 March 2021 |
| First round evaluation completed | 26 July 2021 |
| Sponsor provides responses on questions raised in first round evaluation | 29 September 2021 |
| Second round evaluation completed | 11 November 2021 |
| Delegate's overall benefit-risk assessment and request for Advisory Committee advice | 23 December 2021 |
| Sponsor's pre-Advisory Committee response | 17 January 2022 |
| Advisory Committee meeting | 3 and 4 February 2022 |
| Registration decision (Outcome) | 17 March 2022 |
| Completion of administrative activities and registration on ARTG | 24 March 2022 |
| Number of working days from submission dossier acceptance to registration decision* | 216 |
*Statutory timeframe for standard applications is 255 working days
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
Solution for injection
Strength
160 mg/1 mL
Other ingredients
Glycine, sodium acetate trihydrate, acetic acid, polysorbate 80, water for injection
Containers
Prefilled syringe and prefilled pen
Pack sizes
2
Routes of administration
Subcutaneous
Dosage
The recommended dose of Bimzelx for adult patients with plaque psoriasis is 320 mg (given as 2 subcutaneous injections of 160 mg each) at Week 0, 4, 8, 12, 16 and every 8 weeks thereafter.
For some patients with a body weight equal to or greater than 120 kg, a dose adjustment of 320 mg every 4 weeks after Week 16 may be considered (see Section 5.1 Pharmacodynamic properties, clinical trials).
For further information refer to the Product Information.
Pregnancy category
CDrugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details.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
Bimzelx (bimekizumab) was approved for the following therapeutic use:
Bimzelx is indicated for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.
What is this medicine and how does it work
Bimekizumab is a humanised immunoglobulin G1 kappa (IgG1/κ) monoclonal antibody. It has two identical antigen binding regions that bind and neutralise interleukin (IL) 17A, IL 17F and IL 17AF cytokines. Levels of IL 17A and IL 17F are elevated in several immune mediated inflammatory diseases and drive chronic inflammation and damage across multiple tissues. In human in vitro disease models, dual neutralisation of both IL 17A and IL 17F with bimekizumab suppresses the expression of inflammation related genes and proteins to a greater extent than inhibition of IL 17A alone.
What post-market commitments will the sponsor undertake
- Bimzelx (bimekizumab) is to be included in the Black Triangle Scheme. The Product Information (PI) and Consumer Medicines Information (CMI) for Bimzelx 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 Bimzelx European Union (EU) risk management plan (RMP) (version 1.0, dated 26 August 2021, data lock point 1 November 2019), with Australian specific annex (version 2.0, dated 13 September 2021), included with Submission PM 2020 06299 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).
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 (revision 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 Product Information must be included with the product as a package insert.