MITSUBISHI TANABE PHARMA CANADA announces that its oral formulation for the treatment of amyotrophic lateral sclerosis (ALS) has been included in the provincial drug plan – LeLézard.com

class in: Health
Theme : FDA (Food and Drug Administration) approval.

TORONTO, Aug. 29, 2023 /CNW/ — Today, Mitsubishi Tanabe Pharma Canada (MTP-CA), a subsidiary of Mitsubishi Tanabe Pharma America, Inc. (MTPA), announced that RADICAVA® Oral Suspension (Daravone) now covers the New Brunswick Drug Benefit Program (NBDP) (Special Approval) and Nova Scotia Drug Plan (Exception Status) formulary for the treatment of individuals with Amyotrophic Lateral Sclerosis (ALS), a rapidly progressive neurodegenerative disease.1

“We thank the governments of New Brunswick and Nova Scotia for providing publicly funded access to RADICAVAMD Oral Suspension to eligible ALS patients in the Atlantic provinces,” said Andy Zylak, President of MTP-CA. We will continue to work with decision makers to ensure RADICAVA® Oral Suspension is available in all public drug plans. ?

The efficacy of RADICAVA® Oral Suspension is based on a bioavailability/bioequivalence study comparing it to RADICAVAMDIV, which was approved by Health Canada in October 2018 for the treatment of people with ALS and was shown in a pivotal study to help Slowing of disease contributes to a 33% loss of physical function in patients with ALS.2,3 RADICAVAMDIV infusion is currently available in all provinces and territories of Canada, as well as from Veterans Affairs Canada and Indigenous Services Canada, and is reimbursed by public health insurance.

Today’s announcement is an important step forward for people living with ALS in New Brunswick as it gives them greater access to a new, less burdensome treatment that is helping to slow the loss of physical function in ALS, said Dr. Colleen O’Connell, board-certified physical medicine and rehabilitation physician and professor at Dalhousie University. As a medical physicist specializing in ALS, I think this is good news. We need our patients to have access to approved therapies that have been shown to be effective in treating this devastating disease.

Over time, ALS weakens muscles, which affects the body’s physical abilities and daily activities in people with this progressive neurodegenerative disease, said Dr. Amanda Fiander, Neurologist Maritime Neurology, Halifax. Given the rapid progression of this disease, it is important that patients have access to all approved therapies that can help slow its progression.

According to the ALS Society of Canada, approximately 3,000 Canadians are currently living with ALS4, an incurable disease that affects nerve cells in the brain and spinal cord.5 Most people with ALS die within two to five years of diagnosis.6 The first symptoms The course of the disease can be subtle and it takes an average of 21 months to diagnose ALS in Canada.7,8

“We thank the governments of New Brunswick and Nova Scotia for putting the needs of people living with ALS in Atlantic Canada first,” said Kimberly Carter, President and CEO of the ALS Society of New Brunswick. Brunswick and Nova Scotia. Access to new treatments plays a crucial role in enabling patients and their families to live as well as possible after an ALS diagnosis. We invite other provinces to show the same commitment by ensuring access to all approved therapies for ALS patients, regardless of where they live.

In addition to New Brunswick and Nova Scotia, RADICAVA® Oral Suspension will also be included in public drug plans in Ontario, Alberta, Quebec and British Columbia. It is currently estimated that the majority of private insurance plans in the country cover RADICAVA® Oral Suspension. MTP-CA continues to be in discussions with other provinces, territories and federal agencies to add RADICAVA® Oral Suspension to the covered drug list of other public drug insurance programs.

About RADICAVAMDIV and RADICAVAMD Oral Suspension (Daravone)
RADICAVAMDIV and RADICAVAMD Oral Suspension are indicated for the treatment of patients with amyotrophic lateral sclerosis (ALS). Daravone was discovered and developed by Mitsubishi Tanabe Pharma Corporation (MTPC) over a 13-year period as a treatment for ALS using an iterative clinical development platform. Daravone was approved in Japan and South Korea in 2015 for the treatment of ALS. RADICAVA® was approved by the US Food and Drug Administration (FDA) in May 2017. RADICAVA® for IV infusion received marketing authorization in Canada (October 2018), Switzerland (January 2019), Indonesia (July 2020), Thailand (April 2021) and Malaysia (December 2021).

RADICAVA® Oral Suspension (Daravone) received FDA approval in the United States in May 2022. RADICAVA® Oral Suspension (Daravone) was approved by Health Canada in November 2022.

About Mitsubishi Tanabe Pharma Canada, Inc.
Based in Toronto, Mitsubishi Tanabe Pharma Canada, Inc. (MTP-CA) is a wholly owned subsidiary of Mitsubishi Tanabe Pharma America, Inc. (MTPA) whose mission is to provide treatments for some of the most difficult-to-treat diseases. especially ALS. For more information, visit www.mt-pharma-ca.com/en/.

About Mitsubishi Tanabe Pharma America, Inc.
Headquartered in Jersey City, New Jersey, Mitsubishi Tanabe Pharma America, Inc. (MTPA) is a wholly owned subsidiary of Mitsubishi Tanabe Pharma Corporation (MTPC). Founded by MTPC, the company develops and perfects our offering and markets approved pharmaceutical products for North America. To learn more, please visit www.mt-pharma-america.com or follow us TwitterFacebook or LinkedIn.

SOURCE Mitsubishi Tanabe Pharma Canada, Inc.

Press release sent on August 29, 2023 at 10:05 am and distributed by: