The therapy will be marketed by Mitsubishi Tanabe Pharma Canada (MTP-CA), a unit of Mitsubishi Tanabe Pharma America. MTP-CA was established earlier this year to distribute Radicava and other medicines for difficult-to-treat diseases in Canada.
“We are extremely pleased to receive authorization to bring Radicava to the Canadian ALS community,” Atsushi Fujimoto, president of MTP-CA, said in a press release. “We are committed to providing new treatments for people facing serious diseases and working closely with government bodies to make our medicines accessible to Canadians.”
Under the Priority Review program, Health Canada based its decision on clinical data demonstrating that Radical could slow the deterioration of patients’ motor function, as determined by the ALS Functional Rating Scale-Revised (ALSFRS-R).
Radicava’s pivotal Phase 3 trial (NCT01492686) showed that treatment with 60 mg via intravenous infusion could reduce the decline in ALSFRS-R scores over six months by 33 percent, compared to placebo.
“It is our hope that the approval of Radicava will build momentum for the development of additional therapies, underscoring the importance of research investment and the need for Canadians living with ALS to have timely and equitable access to treatments within the healthcare system,” said Tammy Moore, CEO of ALS Society of Canada.
According to the Toronto-based nonprofit, an estimated 3,000 Canadians have ALS, a disease that affects the nerve cells in the brain and spinal cord. Symptoms of the condition can be subtle at first, and it can take 12 to 14 months to be accurately diagnosed.
Radicava is a free radical scavenger, meaning it helps remove reactive molecules that can cause oxidative stress, which is believed to be one of the causes of nerve cell death in ALS.
Japan and South Korea approved Radical to treat ALS in 2015. Two years later, the U.S. Food and Drug Administration followed suit. Until then, the only available ALS therapy in the United States was Rilutek (riluzole). Radicava is not yet approved in Europe, but an early access program was established to help make it available to patients who may benefit from it in the meantime.
Radicava is administered in 28-day cycles by intravenous infusion, a procedure that may be done at an ALS center, a physician’s office, a free-standing infusion center, or a hospital outpatient department. Home infusion providers can also offer the treatment, depending on individual health insurance and physician oversight.
“For nearly 20 years, Canadians living with ALS have had only one treatment option, making the Canadian approval of Radicava an important and hopeful milestone for a community that still faces a challenging diagnosis,” Moore said.