The addition means the intravenous infusion therapy is now listed on the formulary of the Regie de l’assurance maladie du Quebec, which administers public health and prescription medicine insurance programs there, and is now covered by the province’s public health plan.
As such, it’s available by prescription to patients at a controlled and pre-determined cost.
“The listing of Radicava on the Quebec public formulary is an important step in our long-term commitment to the ALS community in Canada,” Atsushi Fujimoto, president of Mitsubishi Tanabe Pharma Canada, said in a press release. “We thank the government of Quebec for its leadership in making this treatment available to patients in Quebec who are eligible for coverage under the Quebec Public Prescription Drug Insurance Plan.”
It’s estimated that between 2,500 and 3,000 Canada residents live with the progressive neuromuscular disorder.
In the United States, where roughly 5,000 individuals are diagnosed with ALS annually, the treatment use was approved in 2017 and is marketed by MT Pharma America. It was developed by Mitsubishi Tanabe Pharma.
The therapy has a neuroprotective effect and slows the decline of physical functioning in ALS patients by removing free radicals in the nervous system. Free radicals are byproducts of normal cellular processes that produce energy. Normally, they are swiftly removed by the body. If they remain they can cause oxidative stress, leading to damage and cell death. Such stress is thought to be one of the causes of nerve cell death in ALS.
Radicava is administered intravenously — into the bloodstream — in 28-day cycles. The treatment starts with a patient receiving the therapy for 14 consecutive days, followed by a two-week, treatment-free period. Patients then receive an infusion during 10 of the next 14 days, followed by another two-week treatment-free period.
Patients are prescribed 60 mg of Radicava per treatment, and each treatment takes about 60 minutes to administer.
The U.S. Food and Drug Administration’s approval of Radicava was based on the results of Study 19, a placebo-controlled Phase 3 clinical trial (NCT01492686), which evaluated the effectiveness and safety of Radicava in treating ALS.
A recent post hoc analysis of Study 19 suggests the treatment is effective in slowing ALS progression across a year’s use.
The therapy was approved to treat ALS in Japan and South Korea in 2015. It was granted marketing authorization in Canada in 2018, and in Switzerland last year. Mitsubishi Tanabe is continuing discussions with other Canada provinces and territories about further listings under publicly funded medication programs.
Also known as Lou Gehrig’s disease, ALS is a progressive neurological disease that destroys nerve cells and causes disability. The disease causes the death of motor neurons, which control voluntary muscles.
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