Mitsubishi Tanabe Pharma America’s Radicava ORS (edaravone) Receives the US FDA’s Approval for the Treatment of ALS
- The approval was based on the multiple studies i.e., 7 P-I pharmacology studies to evaluate PK, safety, drug-to-drug interactions, dosing, bioavailability & bioequivalence of Radicava ORS vs PBO along with P-III (MCI186-19) trial in patients with ALS. The therapy is as effective as the US FDA-approved Radicava
- The results showed a 33% reduction in loss of physical function @24wks. as measured by the ALSFRS-R. The P-III (MCI186-19) trial showed a safety & tolerability profile in 185 patients with ALS, AEs were reported in ≥10% of patients with Radicava
- The company launched the JourneyMate Support Program which provides educational support & resources to patients who are considering or have been prescribed an MTPA product
Ref: PR Newswire| Image: Mitsubishi Tanabe Pharma
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