First FDA-Approved Treatment for ALS in 22 Years Now Available In U.S.

Mitsubishi Tanabe Pharma America announced RADICAVA (edaravone) is now available for treatment in the United States, which marks the first FDA-approved ALS treatment option in more than 20 years.

RADICAVA (edaravone) is an intravenous therapy indicated for all adult patients diagnosed with amyotrophic lateral sclerosis (ALS). ALS, also known as Lou Gehrig's disease. Earlier before going to the market, RADICAVA has been demonstrated to slow the decline in the loss of physical function in ALS patients by 33 percent in its clinical trial.

the first FDA-approved ALS treatment in more than 20 years

"It gives me great joy that RADICAVA is now available in the U.S.," said Atsushi Fujimoto, President, Mitsubishi Tanabe Pharma America. "After two decades without a new treatment, people with ALS finally have access to a new clinically meaningful treatment option for this horrible, progressive and incurable disease."

RADICAVA is given to patients through an IV and can be administered at an ALS center, physician's office, free-standing infusion center, hospital outpatient department or through a home infusion provider, depending on individuals' health plan and their physicians' determination.

Access to the product and the benefits investigation process is initiated by the HCP and facilitated through the Searchlight Support hub, which provides assistance for people who are prescribed RADICAVA. A Searchlight Support care coordinator can help HCPs identify an infusion service site based on an individual patient's geographic location. Once the benefits investigation is completed, a case manager contacts the patient to explain among other things, benefits and co-pay support options for eligible patients.

ALS is a neurodegenerative disease in which the majority of patients die within two to five years of diagnosis. An estimated 5,000-6,000 Americans are diagnosed each year with ALS, an incurable disease that affects the nerve cells in the brain and spinal cord. Initial symptoms can be subtle at first, and it can take 12 to 14 months to be accurately diagnosed.

The FDA approved RADICAVA (edaravone) on May 5, as a new treatment option indicated for all adult patients diagnosed with amyotrophic lateral sclerosis (ALS). In clinical trials, people given RADICAVA experienced a 33 percent lower rate of decline in the loss of physical function, compared to placebo as measured by the ALS Functional Rating Scale-Revised (ALSFRS-R), a validated rating instrument for monitoring the progression of disability in people with ALS.

RADICAVA is administered in 28-day cycles by intravenous infusion. It takes 60 minutes to receive each 60 mg dose. For the initial cycle, the treatment is infused daily for 14 consecutive days, followed by a two-week drug-free period. All cycles thereafter are infused daily for 10 days within a 14-day period, followed by a two-week drug-free period.

Edaravone was discovered and developed for ALS by Mitsubishi Tanabe Pharma Corporation (MTPC) and commercialized in the U.S. by Mitsubishi Tanabe Pharma America. MTPC group companies began researching ALS in 2001 through a comprehensive clinical platform over a 13-year period.