Approved May 5 by the U.S. Food and Drug Administration (FDA) for all U.S. adults diagnosed with ALS, Radicava has been shown to slow the loss of physical function in ALS patients by 33 percent compared to placebo.
“It gives me great joy that Radicava is now available in the U.S.,” Atsushi Fujimoto, president of Mitsubishi Tanabe Pharma America (MTPA), said in a press release. “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.”
MTPA’s Japanese parent company began researching and developing the drug in 2001 through a comprehensive clinical platform. Japanese and South Korean authorities approved edaravone to treat ALS in 2015.
“After 13 years of clinical research and investment, we have reached a seminal moment, which may shift the treatment paradigm for this terrible disease,” said Tom Larson, MTPA’s chief commercial officer. “As of today, all across the country, conversations between ALS specialists and patients may be substantially different.”
Between 12,000 and 15,000 Americans have ALS, with 5,000 to 6,000 new cases diagnosed annually, according to the Centers for Disease Control and Prevention. ALS progressively attacks and kills nerve cells in the brain and spinal cord that control voluntary muscle movements such as chewing, walking, breathin, and talking. These nerves lose the ability to activate specific muscles, resulting in muscle weakness and eventual paralysis.
“This new treatment may give hope to every person suffering from ALS, and we pray the positive result from this trial will set the tone for more therapies going forward. We all remain committed,” said Dr. Jonathan S. Katz, ALS clinical director at the California Pacific Medical Center in San Francisco.
Radicava is administered in 28-day cycles by intravenous infusion, a procedure that may be done at an ALS center, physician’s office, free-standing infusion center or hospital outpatient department. Home infusion providers can also offer the treatment, depending on individual health insurance and physician oversight.
Access to Radicava therapy is facilitated through Radicava Searchlight Support, which helps people who are prescribed the medication. A Searchlight Support care coordinator can help healthcare providers identify an infusion service site based on where patients live. Once the benefits investigation is completed, a case manager will contact the patient to explain benefits and available co-pay support options.