In February 2016, MTPA’s parent company, the Japanese Mitsubishi Tanabe Pharma Corporation (MTPC), launched MT Pharma America to develop and commercialize novel compounds such as Radicava in the United States market. The move was approved by the U.S. Food and Drug Administration (FDA) in May 2017.
MTPA is based in Jersey City, New Jersey, working to deliver new products that address unmet needs in U.S. patients. MTPA plans to pursue a comprehensive pipeline of products focused on central nervous system (CNS) diseases, like ALS and spinal muscular atrophy (SMA), as well as autoimmune diseases and diabetes.
“As we prepare to launch our first commercial product in the U.S., now is the appropriate time to fully align our corporate name with our parent company, MTPC, the world’s second oldest pharmaceutical company with more than 300 years of experience advancing innovative treatments,” Atsushi Fujimoto, president of MTPA, said in a press release. “We are honored to be a part of this strong and impressive heritage as we commit ourselves to continued innovation in the U.S. to meet patients’ unmet medical needs.”
Radicava was approved in May as a new treatment option for all adults diagnosed with ALS. The therapy is a free radical scavenger, meaning it identifies and eliminates free radicals – molecules that occur as a normal part of the energy-producing process, but usually are removed quickly from the body. If they remain in the body, they can cause oxidative stress, leading to cell damage.
The functioning of Radicava rests on the commonly accepted theory that oxidative stress caused by free radicals is one of the causes of nerve cell death in ALS. Radicava was developed to have a neuroprotective effect that can slow the progression of ALS by removing these free radicals from the nervous system.
The FDA approved Radicava based on the results of a Phase 3 clinical study (NCT01492686), which evaluated the drug’s effectiveness and safety in the treatment of ALS. Based on the ALS Functioning Rating Scale-Revised (ALSFRS-R), a measurement of disability progression. Patients who received Radicava experienced a decline in ALS progression that was 33 percent less than those who received placebo.
Results from this study, which were deemed statistically significant, were published in The Lancet Neurology in July.