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Sunlenca
Sponsor
ARTGs
Device/Product name
Sunlenca
Active Ingredient
Lenacapavir sodium
Date of decision
Published
Submission type
New chemical entity
ATC codes
J05AX31
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 Sunlenca 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 (Orphan or Provisional if applicable) |
Not applicable |
|
Submission dossier accepted and first round evaluation commenced |
2 May 2022 |
|
Evaluation completed |
19 January 2023 |
|
Delegate’s Overall benefit-risk assessment and request for Advisory Committee advice |
3 January 2023 |
|
Sponsor’s pre-Advisory Committee response |
18 January 2023 |
|
Advisory Committee meeting |
3 February 2023 |
|
Registration decision (Outcome) |
23 March 2023 |
|
Completion of administrative activities and registration on ARTG |
27 March 2023 |
|
Number of working days from submission dossier acceptance to registration decision* |
139 |
*Target timeframe for priority applications is 150 working days from acceptance for evaluation to the decision.
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
Solution for injection and film coated tablet
Strength
463.5 mg/1.5 mL (solution for injection) and 300 mg (tablet)
Other ingredients
Tablet: copovidone, croscarmellose sodium, iron oxide black, iron oxide red, iron oxide yellow, macrogol 3350, magnesium stearate, mannitol, microcrystalline cellulose, poloxamer, polyvinyl alcohol, purified talc and titanium dioxide
Injection: macrogol 300 and water for injections
Containers
Vial (solution for injection) and blister pack (tablet)
Pack sizes
2 (vials) and 5 (tablets)
Routes of administration
Subcutaneous (injection) and oral (tablet)
Dosage
Sunlenca should be prescribed by physicians experienced in the treatment of human immunodeficiency virus (HIV). Prior to starting Sunlenca, the healthcare professional should carefully select patients who agree to the required injection schedule.
To help maintain viral suppression and reduce the risk of viral rebound and potential development of resistance associated with missed doses, the healthcare professional should also counsel patients about the importance of adherence to both the scheduled dosing visits and the optimised background regimen.
The recommended Sunlenca treatment regimen in adults consists of an initiation dosing period (oral tablets and subcutaneous injections) and once every 6-months maintenance dosing (subcutaneous injections). Sunlenca oral tablets may be taken with or without food.
If Sunlenca is discontinued, it is essential to adopt an alternative, fully suppressive antiretroviral regimen where possible, no later than 28 weeks after the final injection of Sunlenca.
For further information refer to the Product Information.
Pregnancy category
B1
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 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.
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 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
Sunlenca (lenacapavir sodium) was approved for the following therapeutic use:
Sunlenca, in combination with other antiretrovirals, is indicated for the treatment of adults with multidrug resistant HIV-1 infection for whom it is otherwise not possible to construct a suppressive anti-viral regimen.
What is this medicine and how does it work
Lenacapavir is a multistage, selective inhibitor of human immunodeficiency virus-1 (HIV-1) capsid function that directly binds to the interface between capsid protein (CA) subunits. Lenacapavir inhibits HIV-1 replication by interfering with multiple, essential steps of the viral lifecycle, including capsid-mediated nuclear uptake of HIV-1 proviral DNA (by blocking nuclear import proteins binding to capsid), virus assembly (by interfering with Gag/Gag-Pol functioning, reducing production of CA subunits), and capsid core formation (by disrupting the rate of capsid subunit association, leading to virions with malformed capsids and reduced infectivity).
Lenacapavir has activity that is specific to human immunodeficiency virus (HIV-1 and HIV-2).
Lenacapavir has activity that is specific to human immunodeficiency virus (HIV-1 and HIV-2).
What post-market commitments will the sponsor undertake
- Sunlenca (lenacapavir sodium) is to be included in the Black Triangle Scheme. The PI [Product Information] and CMI [Consumer Medicine Information] for Sunlenca 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 Sunlenca EU [European Union]-risk management plan (RMP) (version 0.1, dated 19 July 2021, data lock point 1 April 2021), with Australia specific annex (version 0.2, dated June 2022), included with Submission PM-2022-00982-1-2, 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.
- The final clinical study report (CSR) for Study GS-US-200-4625 (CAPELLA) should be submitted to the TGA, once available.
- The final clinical study report (CSR) for Study GS-US-200-4334 (CALIBRATE) should be submitted to the TGA, once available.
- For all injectable products the Product Information must be included with the product as a package insert.