U.S. FDA has granted approval for MT Pharma America, Inc. RADICAVA (edaravone), as an intravenous infusion treatment for amyotrophic lateral sclerosis (ALS). People given RADICAVA showed significantly less decline in 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 patients with ALS.
The comprehensive clinical development program for RADICAVA in ALS spanned 13 years and included multiple Phase 3 trials. The pivotal Phase 3 study (MCI186-19), which evaluated 137 people with ALS, formed the basis for the FDA approval of RADICAVA. Data demonstrated patients who received RADICAVA for six months experienced significantly less decline in physical function — by 33 percent or 2.49 ALSFRS-R points (p=0.0013).
The most common adverse reactions that occurred in greater than 10 percent of patients and greater than placebo were bruising (contusion), problems walking (gait disturbance) and headache.2
MT Pharma America is helping to make RADICAVA accessible to all patients who need it and has created Searchlight Support, a patient access program for people with ALS who are prescribed RADICAVA. As soon as a person receives a prescription, he or she can access Searchlight Support, including personal case management, reimbursement support and 24/7 clinical support. Some people with ALS who have received prescriptions for RADICAVA may be eligible to receive additional assistance from MT Pharma America.