Medicines Repurposing Program - Program outcomes and changes

Summary of program outcomes as at July 2025

The Medicines Repurposing Program (MRP, the program) opened on 1 March 2024, with a soft close date of 17 April 2024, for nominations to be considered as part of the first tranche.

• 94 nominations were received before the soft close date. 74 of these nominations were for the same candidate and were considered as a single submission.
• 19 candidate medicines were considered, with 15 candidates meeting the program eligibility criteria.
• Of these 15, 2 candidates have now been selected under the program;
  • HADLIMA (adalimumab) for the treatment of Behcet’s disease (sponsor: Samsung Bioepis), was selected in December 2024 and accepted for evaluation in February 2025. The evaluation is ongoing.
  • KINERET (anakinra) for the treatment of Adult Onset Stills Disease (sponsor: Swedish Orphan Biovitrum), was selected in July 2025. 

Issues encountered and lessons learned

A few common issues were identified with the first tranche of nominations.

Sponsor engagement

While nominators were encouraged to contact pharmaceutical sponsors prior to proposing candidates for the program, it was not a mandatory. A candidate medicine is unable to progress through the program without a willing sponsor application, to enable the regulatory fee waivers to be applied. Lack of sponsor engagement was a key reason candidate medicines were not able to progress.

Nomination by active ingredient

The program received several nominations (different indications) for the same active ingredient. This presented challenges with regards to assessment and discussions with sponsors.

Insufficient supporting evidence

Evidence of established clinical use in Australia was a mandatory requirement.  The inclusion of the use in clinical treatment guidelines and support from clinician groups, were both considered as a supportive evidence base. This enabled an initial review by the program team to determine feasibility to progress through existing TGA registration pathways.

The level of supporting evidence provided by some nominations was insufficient to enable proper consideration of feasibility for the proposed indication. Where clinical guidelines were identified, many of the applications were not sufficiently underpinned by the clinical standard of evidence needed to support registration of the proposed indication.

Program changes

As a result of lessons learned from the first tranche of applications, the following changes apply.

In-principle sponsor support

At the time of application, all nominations for the program, will require in-principle support or an indication of interest from a relevant pharmaceutical sponsor. This address complications arising from nominations of different indications with the same active ingredient, and ensure that nominations considered by the TGA for evaluation.

Relevant pharmaceutical sponsors can be identified by searching the Australian Register of Therapeutic Goods.

Revised nomination process and form

The revised nomination form contains a stronger emphasis on the provision of appropriate clinical and trial evidence to support efficacy requirements for registration of the proposed indication.

The nomination form will be available on request and provided after initial eligibility requirements, including in-principle support from a pharmaceutical sponsor, have been confirmed. The program team welcomes meetings to discuss eligibility requirements by potential nominators.

The program remains open for nominations and applications will be assessed and considered on a rolling basis and as they are received.

Contact

For all enquiries and to discuss program eligibility requirements please email mrp@health.gov.au.