Palovarotene: Resources

Published: September 1, 2025  ~   0

Today, 1st September, palovarotene becomes the first treatment available for Fibrodysplasia Ossificans Progressiva in Australia via the PBS (Pharmaceutical Benefits Scheme).

Therefore it is important for doctors caring for people with FOP to understand the role of palovarotene in treatment, and have information about when and how to use it safely.

Available resources include the following presentations for the 2025 FOP Australia Conference:

 

The International Clinical Council for FOP Treatment Guidelines are also a valuable resource for all aspects of management, and are accessible via the link at the top of every page on this website.

We also encourage doctors and pharmacists to access the Consumer Medicine Information  and full Product Information (PI) and to direct requests for further information regarding prescribing and supply to medinfo.australia@ipsen.com.

 

Milestone announcement: First ever FOP treatment available on the PBS from 1st September 2025

Published: August 23, 2025  ~   0

The 2025 FOP Australia Conference opened today, 23rd August, with a milestone announcement for care of Fibrodysplasia Ossificans Progressiva in Australia by the Minister for Health, Hon Mark Butler MP. Minister Butler has announced that on 1st September, palovarotene will become the first FOP treatment available on the PBS. This will enable subsidised supply to eligible patients throughout Australia.

We would like to acknowledge the generosity and commitment of people living with FOP and their families who contributed their stories to advocate for the ability for others to have the choice of treatment for the first time ever. In hearing their stories, PBAC noted the high and urgent need for treatments for FOP. This PBS listing will also raise the profile of FOP significantly, including in our government and amongst clinicians. It will also help pave the way towards access for future treatments.

It will be more important than ever for clinicians to learn how to recognise FOP, and to learn when palovarotene should be considered and how to use it safely. As part of today’s conference we will have international experts giving guidance on these topics, and many more.

Join us online via links at: https://fopaustralia.org/2025meeting/

Picture: Hon Mark Butler MP, Minister for Health, Australian Government.

New FOP research project launched by CaPPRe/FOP Australia

Published: August 21, 2025  ~   0

FOP Australia are excited to be starting work with CaPPRe (Community and Patient Preference Research) on a project to better understand the needs of people living with Fibrodysplasia Ossificans Progresiva in Australia and New Zealand. We plan that this will help inform our future efforts to advocate for access to services and/or treatments. See more at: https://fopaustralia.org/cappreproject/

 We also encourage people living with FOP in Australia and New Zealand to enrol in the international FOP Registry to keep building global understanding of what FOP is, and how to better help people living with it.

It is also exciting to hear about the Genomics of Rare Disease Registry being established by the Garvan Institute of Medical Research, which aims to help the understanding and identification of rare diseases. They are seeking input from people with many rare diseases, including FOP. You can learn more in this information sheet, or at their website.

Learn more about FOP research in the ‘Understanding FOP’ section of this website, and at the International FOP Association website.

2025 FOP Australia Conference: Online platform now LIVE

Published: August 16, 2025  ~   0
FOP Australia is preparing to bring Australians and New Zealanders with Fibrodysplasia Ossificans Progressiva together, along with clinicians and researchers, for the first time in almost a decade.  The 2025 FOP Australia Conference program is packed with opportunities for everyone to learn more about FOP, treatment and tools either in-person or online on the 22nd-24th August.

For those who can’t attend in-person at the Holiday Inn Express Southbank in Melbourne, we will be live-streaming all sessions on Saturday 23rd and Sunday 24th. And all attendees can check out the latest program details, speakers resources on our Zoom conference platform, which is now live! (If you have already registered for the conference, you should have already received a Zoom link to access the online platform, and do not need to register again)

To register online: You can register directly at the Zoom platform
To register to attend in-person: Please use the forms here, where there is also more detail about what financial assistance you can access to attend the conference.

Meeting details for the private family/clinician meetings on Friday 22nd have been emailed to each individual family directly (including dial-in links). Please get in touch if you have any questions about these sessions.

The conference Welcome and Display Area will be open from 11am on Friday at the conference venue, with displays of resources and information, and opportunities to learn about and contribute to research projects advancing care for FOP. This will include a new FOP Australia project designed to help strengthen our advocacy and lobbying ability.

2024/2025 Annual Report

Published: August 3, 2025  ~   0

The 2024/2025 FOP Australia Annual Report is now available online here and summarises our organisation’s activities during a year which brought many new challenges and opportunities.

As we prepare for our first national gathering in almost a decade, and go through the process of PBAC review of palovarotene as the first ever FOP treatment, we also celebrate the ongoing amazing fundraising efforts throughout our community.

This report has also been emailed directly to all listed members. If you have not received this, please contact info@fopaustralia.org to update your details.

And to stay up to date with news throughout the year, please follow FOP Australia on Facebook, Instagram or LinkedIn.

2025 FOP Australia Conference – 22nd-24th August: Registration now open

Published: May 9, 2025  ~   0

We are excited to invite people with FOP, family members, friends, clinicians, researchers, and supporters in Australia and New Zealand to our first national gathering this decade!  The FOP Australia 2025 conference will be held from the 22nd-24th August 2025 in Melbourne at the Holiday Inn Express Melbourne Southbank. We are currently exploring options for virtual attendance for those unable to attend in person.

Click through to our 2025 FOP Australia Conference page for online registration and further information

Palovarotene recommended to be the first ever PBS-listed FOP treatment in Australia

Published: December 20, 2024  ~   0
The Pharmaceutical Benefits Advisory Committee have recommended that palovarotene be listed as treatment for Fibrodysplasia Ossificans Progressiva. This will enable reimbursed supply within Australia, and is a milestone for the treatment of FOP, and for progress towards a cure.
This decision means that for the first time ever, there will be a potential treatment available for people with FOP and their treating doctors to consider as an option to try to slow/reduce disabling bone growth.
Perhaps even more importantly, this decision also paves the way for consideration of PBAC approvals of other potential FOP drugs in the future. It also creates an important and unique opportunity for us to raise awareness amongst health professionals of the importance of recognising and diagnosing FOP.
We are expecting that the remaining processes required to set up reimbursement will be completed over the next few months. We will keep you updated as that progresses.
The stories of people living with FOP were crucial to this decision. We are deeply grateful to everyone who shared their words, experiences and photos to help PBAC understand what it means to live with FOP, and the importance of a treatment. This has helped regulatory bodies and decision makers learn not just about palovarotene, but about FOP itself, and about the need for more treatments in future. Thank you.
We would also like to acknowledge the support of Rare Voices Australia, Australian Patient Advocacy Alliance, Patient Voice Initiative, and also acknowledge the work of Ipsen, as the pharmaceutical company making the PBAC application.
Read more information about the PBAC decision in the November 2024 outcomes at:

Annual Report 2023/2024

Published: October 6, 2024  ~   0

FOP Australia is happy to share this year’s annual report and thank everyone who has contributed to the work of this organisation in the last financial year.

The full report is accessible here.

Updated international FOP treatment guidelines

Published: July 16, 2024  ~   0

The International Clinical Council on FOP released an updated version of the treatment guidelines in July 2024. This is the first full update since 2019.

Read the International FOP Association summary of updates here.

The full copy of the guidelines is available here, and at the link on the top of every page on our website. We encourage you to share this with your doctors and other clinicians involved in the care of FOP.

TGA approves palovarotene as the first FOP treatment available in Australia

Published: November 30, 2023  ~   0

We are excited to share that the Australian Therapeutic Drug Administration has approved the first ever treatment for Fibrodysplasia Ossificans Progressiva!

Palovarotene capsules (Sohonos) have been approved for use in adults and some children (females 8 years of age or older, males 10 years of age or older) who have FOP. This means that palovarotene is now approved for use, though processes for reimbursement and getting supply of the drug will still need to be developed.

If you have FOP, palovarotene may or may not be an option for you – we encourage you to discuss the potential benefits and side effects, and your individual circumstance, with your treating doctor (particularly with clinical trials of other developing drugs currently open for enrolment in Australia and New Zealand; see trial sites listed at https://fopaustralia.org/updated-clinical-trial-resources/).

This announcement is possible because of clinical trials around the world, including Australia, relying on people with FOP undergoing trial and placebo therapy. The studies showed that palovarotene can possibly have some effect on stopping extra bone formation (heterotopic ossification). We would like to acknowledge the generosity and efforts of all the people who participated in these trials, and their families and research teams, for making this milestone  possible.

Representatives from FOP Australia and Ipsen will be meeting in the coming days, and we look forward to sharing further posts about this announcement. The TGA listing is publically available at:

https://www.tga.gov.au/resources/artg/394001

*Edited 1/12/23 to emphasise that processes for supply and reimbursement of the drug within Australia are still to be developed*