FDA approves another treatment for secondary progressive MS - MS Research Australia

FDA approves another treatment for secondary progressive MS

03 April, 2019
  • The U.S. FDA has approved another medication, cladribine, for active secondary progressive MS (the second one in a week).
  • Cladribine is currently approved in Australia for relapsing remitting MS and is PBS listed.

In further positive news for people living with progressive MS, the U.S. Food and Drug Administration (FDA) has approved the use of cladribine (tradename Mavenclad) for the treatment of relapsing remitting MS (RRMS) and active secondary progressive MS. This is the second medication to be approved for the treatment of active secondary progressive MS in the United States in the last week, bringing the total number of medication options for active secondary progressive MS to three (ocrelizumab , siponimod and cladribine).

Mavenclad is an oral treatment that targets certain types of white blood cells (lymphocytes) that drive the immune attack in MS. It temporarily reduces the number of both T and B lymphocytes and has been shown to decrease the number of relapses and slow the accumulation of physical disability caused by MS, compared to placebo.

In Australia, Mavenclad has already been approved by the Therapeutic Goods Administration (TGA) for the treatment of RRMS and was listed on the Pharmaceutic Benefit Scheme (PBS) for RRMS from 1 January 2019. However, at this stage it is unclear whether the approval of Mavenclad in Australia will be revised and extended to include active secondary progressive MS.
Secondary progressive MS can occur in people who initially experience a relapsing remitting disease course but later transition to experience gradual worsening of neurologic function (accumulation of disability) over time. Active secondary progressive MS is a subgroup of people with MS who continue to experience relapses and/or new lesions on MRI scans, even though they have transitioned to the secondary progressive phase.

Effective treatments for progressive forms of MS is one of the great unmet needs in the MS community and is a strong focus for MS Research Australia together with our partners in the International Progressive MS Alliance. The Alliance brings together MS organisations, academic experts, people living with progressive MS and industry from around the world to unite to accelerate breakthrough treatments for people with progressive MS.

Professor Alan Thompson, Chair of the International Progressive MS Alliance’s Scientific Steering Committee and Dean of University College London Faculty of Brain Sciences commented, “Momentum continues to build with the approval of a third treatment for progressive forms of MS in the United States. Critical progress is being made to address the unmet need of more than one million people living worldwide with progressive MS. While this agent is limited to those with relapses or new disease activity measured by MRI, this and other recent treatment milestones are important and worthy of celebration.”

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