Oral ALS drug 'Radicut Suspension' wins nod in KOR

Expected to offer convenience in administration compared to intravenous injection

Demonstrated efficacy through the Phase 3 MCI186-19 study

The oral formulation of the Amyotrophic Lateral Sclerosis (ALS) treatment, 'Radicut', has been commercialized in South Korea.

The Ministry of Food and Drug Safety (MFDS) granted final marketing approval on December 10 for Tanabe Pharma Korea's Radicut (edaravone) Oral Suspension, an ALS treatment.

The advantage of the Radicut oral suspension is that it reduces the burden on patients by decreasing the number of required hospital visits and minimizing discomfort compared to the existing intravenous (IV) formulation.

This drug was designated for Accelerated Approval by the U.S. FDA in October 2019 and was subsequently approved in May 2022. In countries like the U.S., the Radicut oral suspension is marketed under the product name 'Radicava'.

The suspension formulation of Radicut significantly shortens the administration time compared to the IV injection. While the IV formulation requires the infusion of two ampules (60 mg edaravone) diluted in normal saline over 60 minutes once daily, Radicava ORS takes only a few minutes to administer.

Tanabe Pharma conducted a comprehensive clinical development program for both the intravenous and oral formulations of edaravone over more than 10 years. The approval of Radicut oral suspension was based on data from multiple studies, including the Phase 3 clinical trial MCI186-19, which evaluated 137 patients with ALS.

Notably, the MCI186-19 study measured the ALS Functional Rating Scale-Revised (ALSFRS-R), a validated assessment tool for monitoring disease progression, at Week 24. The oral suspension group showed a 33% slower decline in physical function compared to the placebo group.

In addition, Tanabe Pharma conducted seven Phase 1 clinical pharmacology studies to investigate the pharmacokinetics, safety, drug interactions, dosage, bioavailability, and bioequivalence of Radicava ORS in healthy subjects and in ALS patients with or without a Percutaneous Endoscopic Gastrostomy (PEG) tube or a Nasogastric (NG) tube.

Furthermore, a 24-week global Phase 3 clinical trial demonstrating the safety and tolerability profile of 'Radicava ORS' treatment in 185 ALS patients was also conducted. A Phase 3 clinical study evaluating the long-term safety and tolerability for up to 96 weeks is currently ongoing.