Radicava Oral Suspension Approved in Canada to Treat ALS

Oral treatment follows same dosing regimen as intravenous administration

Teresa Carvalho, MS avatar

by Teresa Carvalho, MS |

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Radicava Oral Suspension, an oral formulation of edaravone, has been approved in Canada for treating amyotrophic lateral sclerosis (ALS).

Mitsubishi Tanabe Pharma Canada (MTP-CA), the subsidiary of Mitsubishi Tanabe Pharma America that markets Radicava in Canada, has announced plans to make the oral formula available to patients in the country as soon as possible. It was approved earlier this year in the U.S., where it has since been administered to nearly 2,000 patients under the brand name Radicava ORS.

“A diagnosis of ALS is life altering, but recent medical advances can help to slow the loss of function,” said Angela Genge, director of the clinical research unit at The Neuro (Montreal Neurological Institute-Hospital), in a MPT-CA press release. “The availability of new treatment options is good news for patients and families impacted by ALS.”

The oral formulation was designed to be as effective as the intravenous (into-the-vein) formulation, Radicava (edaravone), but it’s more convenient to use because it can be self-administered at home and doesn’t require traveling to an infusion center. It’s available in a portable bottle that includes a 5 mL oral syringe that contains 105 mg of the active ingredient, edaravone.

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It’s recommended that Radicava Oral Suspension be administered orally or via a feeding tube in the morning after overnight fasting and patients should avoid eating food for about an hour after taking it.

The oral treatment follows the same dosing regimen as Radicava. In an initial treatment cycle, patients receive daily treatments for 14 successive days followed by a two-week period without it. After that, it should be taken daily for 10 out of 14 days, followed by two-weeks of no treatment.

Priority review for Radicava ORS

“Today, we are excited to be able to provide patients and physicians with Radicava Oral Suspension, an oral formulation of edaravone,” said Atsushi Fujimoto, president of MTP-CA.

Health Canada’s decision to approve Radicava Oral Suspension followed a notice of compliance from the regulatory agency, as well as priority review being granted, which aims to shorten the review time from 10 to about six months. A notice of compliance is granted upon positive review of a regulatory submission and means the medication complies with defined standards of safety, effectiveness, and quality as set by Canadian law.

“Time is of the essence for Canadians living with ALS, and Health Canada’s approval of oral edaravone under a priority review pathway underscores the importance of equitable and expedited access to effective treatments,” said Tammy Moore, CEO of the ALS Society of Canada. “We are hopeful this approval will continue to build momentum for ongoing investment in innovative research to address the urgent unmet needs of Canadians affected by ALS.”

Other countries, including Japan and Switzerland, have also agreed to review applications seeking the approval of the oral formulation.

Edaravone works to reduce a type of cellular damage called oxidative stress, which is believe to contribute to ALS progression.

Time is of the essence for Canadians living with ALS, and Health Canada’s approval of oral edaravone under a priority review pathway underscores the importance of equitable and expedited access to effective treatments.

The into-the-vein formulation was first approved for ALS in 2015 in Japan and South Korea, and was approved in the U.S. in 2017 and in Canada in 2018. It’s also cleared for use in Switzerland, although edaravone is not approved in other European countries.

The approval of Radicava Oral Suspension was supported by a number of clinical trials, including the Phase 3 trial (NCT01492686) that supported the approval of the intravenous formulation, which showed edaravone leads to a 33% reduction in functional decline compared with a placebo.

It also showed the oral formulation and Radicava deliver to the body similar amounts of the active ingredient and data from a Phase 3 trial (NCT04577404) showed Radicava Oral Suspension was generally safe and well tolerated and slowed functional decline to a degree comparable to what Radicava did.

“Mitsubishi Tanabe Pharma Canada is committed to addressing the unmet needs of those living with ALS, and we are proud to be leading the discovery and development of important treatment options that benefit the ALS community,” Fujimoto said.