First FDA-approved treatment for ALS in 22 years now available in U.S.
Mitsubishi Tanabe Pharma America announced RADICAVA (edaravone), an intravenous therapy indicated for all adult patients diagnosed with amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's disease, is now available for treatment in the U.S. RADICAVA, the first FDA-approved ALS treatment option in more than 20 years, has been demonstrated to slow the decline in the loss of physical function in ALS patients by 33 percent in its clinical trial.
"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.
"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, Chief Commercial Officer, Mitsubishi Tanabe Pharma America. "As of today, all across the country, conversations between ALS specialists and patients may be substantially different. We are all extremely proud and excited to be a part of bringing RADICAVA and new hope to patients in the U.S."
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.
"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 Jonathan S. Katz, M.D., ALS Clinic Director, Forbes Norris MDA/ALS Research and Treatment Center at California Pacific Medical Center.
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.