Teva secures PBS listing of motor neurone disease therapy

Teva has welcomed the inclusion of Radicava (edaravone) IV infusion on the Pharmaceutical Benefits Scheme (PBS) for amyotrophic lateral sclerosis (ALS) where treatment is initiated within two years of disease onset.

ALS, a subtype of motor neurone disease (MND), progressively damages the nerve cells in the brain and spinal cord, robbing patients of their ability to walk, eat, speak, and ultimately breathe independently.

Radicava was developed by Mitsubishi Tanabe Pharma and is commercialised in Australia by Teva Pharma. The therapy received Therapeutic Goods Administration (TGA) approval in February 2023, followed by a positive Pharmaceutical Benefits Advisory Committee (PBAC) recommendation for PBS listing in March 2024.

“Increased awareness, early diagnosis and early treatment are critical to improving outcomes for Australians living with ALS,” said Professor Matthew Kiernan, CEO and Institute Director at Neuroscience Research Australia.

“The increased availability of treatment options provides hope for caregivers and patients with ALS, and the broader MND community,” said Clare Sullivan, Chief Executive Officer, MND Australia.

A recent systematic review and meta-analysis pooling Radicava data from 12 studies and 2,845 participants found a statistically significant improvement in survival rates at 18, 24, and 30 months, without a corresponding increase in adverse events. Complementing this, a retrospective analysis of real-world data suggested that Radicava was linked to fewer reported disease progression milestones and deaths compared to those not receiving the drug.

“For those living with any type of MND, access to treatment options is important,” said Neale Daniher AO, Co-Founder and Patron, Fight MND.

“We welcome this opportunity from the Australian government to make Radicava IV infusion available on the PBS for eligible patients with ALS,” said Jim Margaritis, Vice President-APAC Cluster Head and General Manager, Australia and New Zealand for Teva.

From 1 April 2025, Mitsubishi Tanabe discontinued the IV formulation of the drug in the US and is only distributing the branded oral suspension, Radicava ORS.

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