MTPA joins with ALS/MND patient registry with goal of better care

Consortium collects data on natural history of ALS, use of therapies like Radicava

Mary Chapman avatar

by Mary Chapman |

Share this article:

Share article via email
A researcher studies samples of fluids on slides placed on a microscope alongside a rack of test tubes and a beaker.

To better understand amyotrophic lateral sclerosis (ALS) and improve patient care, Mitsubishi Tanabe Pharma America (MTPA) is partnering with the ALS/MND Natural History Consortium in collecting real-world data on people with the progressive neurodegenerative disorder.

The collaboration will give MTPA access to the consortium’s data repository, containing demographic, baseline, and longitudinal clinical and scientific data on people with ALS and other motor neuron disorders (MNDs).

The company also will gain access to clinical data covering patients using its ALS treatments, Radicava (edaravone) and the oral formulation Radicava ORS, dating back when the consortium was founded in 2015.

Recommended Reading
A large bell labeled

FDA final approval decision on NurOwn for ALS due by year’s end

Radicava’s 2017 approval marked first new ALS treatment for US in 22 years

Both formulations were developed by Mitsubishi Tanabe Pharma and are marketed in the U.S. by its subsidiary MTPA. They are used to slow functional decline and extend survival in those with ALS.

When Radicava was approved by the U.S. Food and Drug Administration in 2017, preceded by approvals in Japan and South Korea, it became the first new ALS treatment available in the U.S. in more than 20 years. To date, the formulations have been used to treat some 10,000 ALS patients in that country, according to MTPA.

“Access to real-world data is critical with complex and difficult-to-treat diseases like ALS,” Gustavo A. Suarez Zambrano, MD, MTPA vice president of medical affairs, said in a company press release. “This collaboration will enable us to leverage a comprehensive database of real-world and retrospective clinical trial findings, continuously advancing our scientific understanding of ALS and how to improve care for people living with this disease.”

More than 2,100 ALS patients from across 10 participating clinics in the U.S. and Italy are currently enrolled in the consortium. Its database uses NeuroBANK, a patient-centric clinical research platform managed by the Neurological Clinical Research Institute (NCRI) at Massachusetts General Hospital (MGH).

The consortium’s mission is to collect real-world ALS and MND data that could aid scientists in disease research and help to inform clinical trial design. The overarching aim is improved ALS knowledge and care.

“Through this collaboration, MTPA joins the ranks of visionary companies that understand the importance of capturing high-quality real-world data that help us to better understand, better diagnose and ultimately find new treatment options for ALS,” said Alex Sherman, director of the Center for Innovation and Biomedical Informatics at the NCRI and the study’s principal investigator. “We hope to see this momentum continue and are confident our collaboration with MTPA will have a meaningful impact on the ALS community.”