China Becomes 6th Country to Approve Edaravone Infusion Therapy for ALS

People in China with amyotrophic lateral sclerosis (ALS) can now access edaravone (brand names Radicava, Radicut, among others), following its approval by the National Medical Products Administration, the country’s regulatory agency.

The infusion therapy (delivered into the veins) is meant to slow ALS progression and will be sold by Tianjin Tanabe Seiyaku, a subsidiary of the treatment’s Japan-based developer Mitsubishi Tanabe Pharma Corporation (MTPC), the company announced.

China is the sixth country to approve edaravone for ALS. Japan was the first country to do so in 2015, followed by South Korea, U.S., Canada, and Switzerland. (Japan first approved edaravone in 2001 to help people recover from stroke).

In the U.S. the treatment is sold under the brand Radicava, and was approved in 2017, the first new ALS therapy approved by the U.S. Food and Drug Administration in more than 20 years. Since then, more than 4,000 people with ALS have received treatment with Radicava and over 1,100 healthcare providers have prescribed it to their ALS patients, Mitsubishi Tanabe Pharma America (MTPA), the American subsidiary of MTPC, reports.

According to the company, nearly 92% of patients who sought insurance coverage in the U.S. for Radicava have received the coverage, and about 70% of patients have been on treatment for six months or more.

“Our focus continues to be on how we can make a meaningful difference in the lives of people with ALS and their families,” MTPA president, Atsushi Fujimoto, said in a news release.

“We are pursuing research into biomarkers in ALS and development of an oral formulation of edaravone. Whether it’s through our clinical research or providing resources to help families understand the disease and navigate care, we remain as dedicated as ever to continuing that mission.”

Edaravone is a free-radical scavenger, thought to remove free radicals that are toxic and accumulate in the nervous system of ALS patients. By removing these free radicals, the medicine protects motor neurons from oxidative damage, thereby delaying the decline in muscle strength and progressive muscle atrophy in patients.

The treatment is currently only available as an infusion therapy that can be given to patients at home or in a clinic.

ALS is one of the most well-known neuromuscular diseases, affecting nearly two in 100,000 people worldwide. About 20,000 to 30,000 are estimated to have the disease in China, while an estimated 5,000 to 6,000 are diagnosed each year with ALS in the U.S.