Thousands in US use ALS treatment Radicava ORS, company says
Mitsubishi Tanabe Pharma marks therapy's 3-year anniversary
Three years after its approval in the U.S., Radicava ORS (edaravone) has been prescribed by more than 1,300 healthcare providers to more than 13,500 people living with amyotrophic lateral sclerosis (ALS) in the country, according to the company that markets it.
First approved as an into-the-vein infusion called Radicava, the medication has been available since 2022 as a more convenient oral suspension called Radicava ORS. Both forms provide the same benefit and are marketed in the U.S. by Mitsubishi Tanabe Pharma America (MTPA).
“Reflecting on the past three years since the approval of Radicava ORS, I am encouraged by the progress we have made in providing a treatment for the thousands living with ALS in an oral formulation,” Yasutoshi Kawakami, MTPA’s president, said in a company press release.
ALS occurs due to the gradual loss of motor neurons, nerve cells that control voluntary movements. The exact causes of ALS aren’t fully understood, but oxidative stress seems to be one key mechanism involved in motor neuron damage.
Oxidative stress caused by an imbalance between the production of toxic reactive molecules during normal cellular metabolism and the body’s ability to neutralize them with antioxidants. This leads to an excess of oxygen-containing molecules that cause significant damage to cellular components.
Radicava for ALS
Both Radicava and Radicava ORS contain the same active ingredient, edaravone, which acts as an antioxidant that scavenges oxygen-containing molecules. By neutralizing these toxic molecules, it is expected to help prevent the loss of motor neurons and slow disease progression.
Radicava ORS was approved in the U.S. in May 2022 and became available the following month. Since then, more than 1,378 healthcare providers have prescribed Radicava ORS to at least one of their patients, MTPA said. Between June 2022 and March 2024, 82% of patients who began treatment with Radicava ORS continued for at least three months.
During the initial treatment cycle, patients take Radicava ORS every day for 14 days, followed by 14 days without the medication. Afterward, maintenance treatment begins, with patients taking Radicava ORS for 10 out of every 14 days, followed by another 14-day break.
Patients take Radicava ORS on an empty stomach in the morning, and are advised to wait at least an hour before eating or drinking anything except water. Patients should use the measuring syringe provided with the medication rather than household spoons, MTPA says.
The most common side effects reported with Radicava ORS after six months of use as part of a Phase 3 clinical study (NCT04165824) were muscle weakness, falls, and fatigue. With Radicava, the most common side effects during clinical testing were bruising, problems walking, and headache, but more serious side effects have been reported with real-world use.
To support patients and their caregivers, MTPA offers JourneyMate, a program that provides education and personalized help for those taking Radicava ORS. Patients can also reach out to program specialists by calling the toll-free number 1-855-457-6968.
The company also runs the Share Your Story program to highlight stories from patients about their experiences with Radicava ORS. The goal is to build a community where patients can find support.
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