Quarterly Update

Yet another promising new drug has been approved by the FDA for treatment of relapsing forms of multiple sclerosis. Tyruko is a biosimilar disease-modifying therapy (DMT) – meaning it is functionally the same and has been shown to work throughout the body just as another drug has – in this case, Tysabri. Tyruko will be administered the same (monthly infusion) and has no clinically meaningful differences from Tysabri. They have the same safety, efficacy and side effects. Like Tysabri, Tyruko ultimately prevents lymphocytes from crossing the blood-brain barrier into the central nervous system, which reduces damage to nerve cells and can halt disease activity. This advancement will offer quality treatment at significant cost savings, therefore expanding accessibility to improved healthcare.

This exceptionally innovative feat has been made possible through research efforts supported by donors like you. Biosimilars will offer more accessibility and promise for people affected by relapsing MS because not only will this new treatment option soon be available, but Tyruko is the first biosimilar in the country to be approved for treatment of any diagnosis.

We might equate a biosimilar to a generic – generic treatment options tend to follow the approval and administration of nonbiologic drugs, whereas biosimilars are made for biologic drugs, or drugs that are comprised of living organisms.

“Biosimilars are an important treatment option because they have no clinically meaningful differences from their reference medicines. Prescribing them can increase accessibility to affordable medications, improve adherence and help contain healthcare costs,” said Bari Talente, Executive Vice President, Advocacy and Healthcare Access.

The costs of biologic treatments like Tysabri can be exorbitant due to the extensive research and testing required to ensure they are safe and effective for those who need them. Infusible DMTs are notoriously linked to their high expense. While the cost of Tyruko has not yet been announced, a recent study shared that the average annual cost of Tysabri exceeds $100,000.

Biologic drugs — like Tysabri —may be sold for 12 years under their patent restrictions, at which point other drugmakers are allowed to create biosimilar iterations. This influx of options and market competition can lead to lower costs for biosimilars. And due to the near identical nature of efficacy, biosimilars don’t require additional testing and study, which further relieves expense associated with the debut of new drugs. The availability and accessibility of biosimilar treatments can alleviate cost burden on families while offering the latest innovative medicine needed to treat the symptoms of their diagnoses. Discoveries like this are monumental to the world of MS research, and only made possible through the intentional support of donors like you.

Learn more about biosimilars and their place in the MS movement with the recent Ask an MS expert episode, hosted by Jon Strum.

This past summer marked several exciting milestones for the Pathways to Cures global initiative to discover cures for MS. After the inaugural Pathways to Cures Global Summit in May, when nearly 200 of the field’s leading MS experts representing 15 countries reviewed progress and priorities to accelerate global alignment on cures, a Global Strategy Group was established.

In June, the Society announced a commitment of $19.4 million in support of launching 40 promising MS research projects. This investment reflects the Society’s commitment to advancing promising areas outlined in the Pathways to Cures roadmap to stop MS, restore function and end MS.

The new projects include 15 new research grants, 29 new fellowships and early career awards to support the MS workforce plus strategic initiatives to boost the impact of two federally funded clinical trials.

Highlights include:

Stopping MS in its tracks:

• A team at Cleveland Clinic and collaborators are following up with participants from a previous clinical trial to identify a brain imaging biomarker that better predicts whether a therapy can slow MS progression.
• Researchers in Australia are using advanced statistical methods to understand diet’s role in slowing MS progression.

Restoring what’s been lost:

• A postdoctoral fellow and team at Johns Hopkins University are exploring the effect of a molecule produced in the gut on the brain and whether taking related dietary supplements may help restore nerve-insulating myelin that is damaged in MS.
• Researchers at the University of Colorado are testing whether electrical nerve stimulation can reduce fatigue in a clinical trial involving people with MS.

Ending MS forever:

• A team in Toronto is mapping out the earliest signs of MS in people who had mononucleosis (mono) in the past, a viral infection that increases a person’s chances of developing MS.
• Stanford University scientists are exploring novel technology with an eye toward developing a vaccine that may prevent the Epstein-Barr virus from triggering MS.

Click for a larger version of the timeline.

This most recent funding is part of the Society’s annual investment of over $30 million for more than 200 new and ongoing MS research studies around the world, including support for the International Progressive MS Alliance — a global effort to accelerate the development of effective treatments for people with progressive MS to improve quality of life worldwide.

Next year, an updated Pathways to Cures Roadmap reflecting conversations from the Summit and the latest scientific understandings will be published in the Multiple Sclerosis Journal. A global landscape analysis will shed light on the state of MS research funding worldwide and help MS organizations and other funders better align initiatives and investments in support of Pathways to Cures.