Wednesday, August 30, 2023
Mitsubishi Tanabe Pharma Canada's subsidiary, MTP-CA, has announced that RADICAVA® Oral Suspension (edaravone) has been included in the New Brunswick Drug Plan (NBDP) formulary with special authorization and the Nova Scotia Formulary with exceptional status. This step is intended to provide treatment for individuals suffering from amyotrophic lateral sclerosis (ALS), a rapidly progressing neurodegenerative disease.
Andy Zylak, President of MTP-CA, expressed gratitude to the New Brunswick and Nova Scotia Governments for their support in granting ALS patients in the Atlantic provinces access to RADICAVA® Oral Suspension through publicly funded means. Zylak also conveyed the company's ongoing commitment to collaborating with decision-makers to ensure RADICAVA® Oral Suspension becomes accessible via all publicly funded drug plans.
The effectiveness of RADICAVA® Oral Suspension was established through a study comparing its bioavailability/bioequivalence to RADICAVA® IV, which Health Canada authorized in October 2018 for ALS treatment. Clinical trials of RADICAVA® IV demonstrated a 33% slowdown in the decline of physical function in ALS patients. RADICAVA® IV Infusion is presently available and reimbursed through public formularies across Canada, including Veterans Affairs Canada and Indigenous Services Canada.
Dr. Colleen O'Connell, a specialist in Physical Medicine and Rehabilitation and a Professor at Dalhousie University, lauded the announcement, highlighting the significance of expanding access to a treatment that has demonstrated benefits in mitigating ALS-related physical function decline. Dr. Amanda Fiander, a neurologist at Maritime Neurology in Halifax, underscored the necessity of approved therapies to counter the swift progression of ALS and alleviate its impact on patients' physical function.
According to the ALS Society of Canada, roughly 3,000 Canadians are presently living with ALS, an incurable condition affecting nerve cells in the brain and spinal cord. The majority of ALS patients pass away within two to five years of diagnosis, with symptoms often initially subtle and the diagnosis process taking an average of 21 months in Canada.
Kimberly Carter, President and CEO of ALS Society of New Brunswick and Nova Scotia, commended the commitment of both provinces to prioritize the needs of ALS patients and urged other provinces to follow suit by ensuring access to approved ALS therapies regardless of geographical location.
Apart from New Brunswick and Nova Scotia, RADICAVA® Oral Suspension is part of public drug plans in Ontario, Alberta, Québec, and British Columbia. It is estimated that the majority of private insurance plans in Canada also cover RADICAVA® Oral Suspension. Mitsubishi Tanabe Pharma Canada is actively engaging in discussions with other provinces, territories, and federal agencies to incorporate RADICAVA® Oral Suspension into additional publicly funded drug programs.
RADICAVA® IV and RADICAVA® Oral Suspension (edaravone) are indicated for ALS treatment. Edaravone was developed for ALS by Mitsubishi Tanabe Pharma Corporation (MTPC) and received approval in Japan and South Korea in 2015. RADICAVA® gained approval from the U.S. FDA in May 2017. RADICAVA® IV Infusion obtained marketing authorization in Canada (October 2018) and other countries. RADICAVA® ORS (edaravone) received U.S. FDA approval in May 2022, while RADICAVA® Oral Suspension (edaravone) was authorized by Health Canada in November 2022.