The treatment was approved in Canada in October 2018, and has since been under the regulatory process that determines how, where, and at what cost it will be available to Canadians.
“This milestone is an important step in our long-term commitment to make a significant difference to the lives of Canadians struggling with this horrible progressive disease,” Atsushi Fujimoto, president of MTP-CA, said in a press release.
“We are deeply dedicated to the ALS community in Canada and will continue to work hard to deliver on our commitment,” he added.
Initially, the treatment will be available to participants of the MTPC Edaravone Supply Program and to people with private insurance who receive reimbursement approval through the MTP Patient Support Program. Those interested in knowing more about these programs should talk directly with their ALS clinicians.
According to Health Canada, people who personally import the treatment to Canada, either by mail or in person, will be able to continue to do so until the beginning of April 2020, at which point the agency plans to determine whether access via this pathway is still required.
As of today, Radicava is not available in the public healthcare system. MTP-CA is negotiating aspects such as the price of the therapy with the pan-Canadian Pharmaceutical Alliance — an initiative that conducts joint negotiations for approved treatments in Canada.
Radicava was developed by Mitsubishi Tanabe Pharma America and is marketed by MTP-CA in Canada. It is an intravenous infusion that acts by removing free radicals from the body. Free radicals are natural products of cellular activity, but when they build up, they can cause cellular damage.
Free radicals have been associated with nerve cell death and muscle atrophy (shrinkage) in ALS patients, so removing them from the body can slow disease progression.
Radicava was the second ALS treatment approved in Canada, following the approval of Rilutek (riluzole) nearly 20 years ago. The therapy is currently approved for the treatment of ALS in Japan, South Korea, the U.S, Canada, Switzerland, and China.