Mitsubishi Tanabe Pharma America (MT Pharma America) has enrolled more than 700 sites of care in its newly created National Infusion Center Directory to help physicians identify local infusion centers for amyotrophic lateral sclerosis (ALS) patients who are prescribed Radicava (edaravone).
Radicava is an intravenous (IV) infusion treatment that was approved last May by the U.S. Food and Drug Administration (FDA) for the treatment of ALS. The medicine should be available for U.S. patients in August.
In ALS, damaging oxidative processes occur at a higher than normal rate. Radicava was designed to help control the excessive oxidative stress in the body.
Radicava is the first treatment for ALS approved in 22 years. The approval was based on data from a Phase 3 clinical trial (NCT01492686) conducted in Japan, which demonstrated the drug’s ability to slow the rate of decline in loss of physical functioning in ALS patients.
Results from the six-month trial, which randomized 137 patients to receive either Radicava or a placebo, showed that the medicine reduced the rate of decline in physical ability by 33% compared to the placebo.
Once available, Radicava will be administered through an IV, which patients can receive at an outpatient center, at their own homes, or at a healthcare provider’s office, depending on the patient’s health plan.
Patients are encouraged to schedule an appointment with their healthcare provider before Radicava is available to determine if they’re eligible for the treatment and to identify the appropriate site of infusion, based on their needs.
The National Infusion Center Directory is available by calling 1-844-SRCHLGT (1-844-772-4548), which will assist healthcare providers by identifying a list of local centers that might be most convenient for their patients, based on location, insurance plan, and center schedules.
“Our teams have been working diligently to enroll as many infusion center sites as possible in advance of Radicava becoming available in the U.S. to ensure the treatment process is as smooth and convenient as possible for physicians and their patients,” Atsushi Fujimoto, president of MT Pharma America, said in a press release. “These efforts are part of our ongoing commitment to help people with ALS and caregivers access the support they need and deserve.”
In a recent ALS News Today telephone interview, an ALS Association executive said Radicava is being welcomed with “a great deal of excitement” in the ALS community, not only because of its potential to treat ALS but also because there is hope that its approval will lead to future treatment authorizations.
Calaneet Balas, the ALS Association’s executive vice president of strategy, said that understandably, “there are a lot of questions and maybe a little bit of anxiety” surrounding Radicava’s introduction next month, but also “a great amount of excitement. I think, if anything, this approval has brought true hope to this community,” she said.
A significant milestone introduced by Radicava is that it led the FDA into moving the drug forward quickly “because of such a grave, unmet need in a really terrible disease,” which is nearly unprecedented from the FDA, Balas added.
Until more is known, the ALS Association is working on preparations for Radicava’s arrival, especially as “this is a space that hasn’t had new therapy for a long time, so there will be a lot of questions, a long learning curve,” Balas said in the interview.