Alexion, AstraZeneca Rare Disease's Ultomiris® (ravulizumab rch) has been listed on the Pharmaceutical Benefits Scheme (PBS) for adults with generalised myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive (Ab+). The Minister for Health and Ageing, The Hon Mark Butler MP, made the announcement at today's World Rare Disease Day event at Parliament House.
Ultomiris is now available on the PBS for people with acute, severe gMG at high risk of rapid deterioration; for short term disease control as other treatments take effect; and for people not responding, intolerant or contraindicated to other therapies.[1],[2]
gMG is a rare, debilitating, chronic, autoimmune neuromuscular disease that leads to a loss of muscle function and severe weakness. Those living with gMG may initially experience slurred speech, double vision, droopy eyelids and weakness, with symptoms becoming more severe as the disease progresses, including extreme fatigue, difficulty swallowing, choking and respiratory distress. [3],[4]
Around 3,000 Australians are estimated to be living with gMG[5],[6],[7] and approximately 80 per cent are AChR Ab+.2 gMG most commonly begins in females before the age of 40, or in males after the age of 60, but can occur at any age including in childhood.[8],[9],[10]
Leading Australian neurologist and gMG expert, Associate Professor Stephen Reddel, said: "Generalised myasthenia gravis can be a debilitating disease for patients, causing unexpected and severe symptoms which can make many daily tasks difficult.
"Sometimes, in more severe cases, muscles that control breathing, swallowing and body movements are impacted resulting in symptoms such as difficulty speaking, swallowing, respiratory issues and muscle weakness, which can be very serious. Having new treatments available will give patients and clinicians more options to treat the disease," concluded A/Prof. Reddel.
Susan White, Chairperson of Myasthenia Alliance Australia said: "It is such an important day for myasthenia gravis patients as they will now have PBS access to a new treatment for this condition. It's been a long journey to see this medicine reach the PBS and we thank the government for making this innovative medicine accessible for Australians."
Nicole Gaupset, General Manager, Alexion Australasia, said: "At Alexion, we are committed to bringing innovation to rare disease patients, so we are excited that our treatment for gMG will now be available through the PBS. It's been a long road to reach this point, but we have never given up in Australia."
Treatment options should be discussed with a patient's clinician.
▼ This medicine is subject to additional monitoring in Australia. This will allow quick identification of new safety information. Patients can report side effects to their doctor or to the TGA via www.tga.gov.au/reporting-problems. Healthcare professionals can report any suspected adverse events to www.tga.gov.au/reporting-problems.
Adverse events can also be report to Alexion at https://contactazmedical.astrazeneca.com.
WARNING: SERIOUS MENINGOCOCCAL INFECTIONS ULTOMIRIS increases the risk of meningococcal infections. Life-threatening meningococcal infections/sepsis have occurred in patients treated with Ultomiris. Meningococcal infection may become rapidly life-threatening or fatal if not recognised and treated early. Immunise patients with meningococcal vaccines at least 2 weeks prior to administering the first dose of ULTOMIRIS, unless the risks of delaying ULTOMIRIS therapy outweigh the risk of developing a meningococcal infection (refer to full PI, section 4.4 Special Warnings and Precautions for Use for additional guidance on the management of the risk of meningococcal infection). Refer to the most current edition of the Australian Immunisation Handbook for meningococcal vaccination guidelines. Patients who initiate ULTOMIRIS treatment less than 2 weeks after receiving meningococcal vaccination must receive treatment with appropriate prophylactic antibiotics until 2 weeks after vaccination. Vaccination reduces, but does not eliminate, the risk of meningococcal infections. Monitor patients for early signs of meningococcal infections and evaluate immediately if infection is suspected. Patients should be advised about the signs and symptoms of meningococcal infection and to seek medical care immediately if they occur. |
Please review the full Ultomiris Product Information before prescribing, which can be accessed at https://rss.medsinfo.com.au/xi/pi.cfm?product=xipultoi
The Australian Ultomiris Consumer Medicine Information can be accessed at https://rss.medsinfo.com.au/xi/cmi.cfm?product=xicultoi
PBS Information: From 1 March 2026: Ultomiris is listed on the PBS as a Section 100 item for the treatment of generalised myasthenia gravis (gMG). Refer to PBS Schedule for full authority information.
–
