
- June 2022
- Volume 5
- Issue 3
FDA Approves Oral Version of Edaravone for ALS
The oral version offers the same efficacy as the previously approved intravenous treatment.
The FDA has approved an oral formulation of edaravone, marketed as Radicava ORS (Mitsubishi Tanabe Pharma America), for the treatment of
The drug, which is meant to slow loss of physical function in ALS, can now be administered in several ways to best accomodate the different needs of patients with ALS.
“ALS is a progressive disease that, due to its heterogenous nature, impacts patients at different rates with varying symptoms,” said Tulio Bertorini, MD, professor of neurology, The University of Tennessee Health Science Center, in a statement. “Therefore, it is crucial that patients have treatment and formulation options that accommodate their own unique needs, and Radicava ORS provides HCPs who have prescribed their ALS patients edaravone with an alternate delivery option.”
The new oral formulation—which offers the same efficacy as the intravenous version—is designed for ease of use, with a 5 mL dose contained in a portable bottle that does not require refrigeration or reconstitution.
The approval is supported by evidence from the IV edaravone phase 3 pivotal trial, Study 19 (NCT01492686), which evaluated 137 patients with ALS, demonstrating that treatment with edaravone slowed loss of physical function by 33% compared with placebo at 24 weeks based on the ALS Functional Rating Scale-Revised. Additional safety and efficacy data were collected from several phase 1 trials as well as an additional global phase 3 trial (NCT04165824). An ongoing phase 3 study (NCT04577404) is also examining the long-term safety and tolerbility of oral edaravone over 96 weeks.
The original intravenous formulation was FDA-approved on May 5, 2017, and is administered in 28-day cycles, with each patient receiving a 60 mg dose over the course of a 60-minute infusion. The oral formulation requires a 14-day induction period of daily administration followed by a 2-week drug-free period. This initial cycle is followed by a 10-day treatment cycle every 14 days, which is followed by a 14-day drug-free period.
The most common adverse events associated with edaravone are bruising, gait disturbances, and headache, as well as fatigue.
In addition to the ongoing long-term phase 3 trial, Mitsubishi Tanabe has also recently launched the
Mitsubishi Tanabe Pharma's
REFERENCE
Mitsubishi Tanabe Pharma America Announces FDA Approval of RADICAVA ORS® (edaravone) for the Treatment of ALS. News release. Mitsubishi Tanabe Pharma America. May 13, 2022. https://www.prnewswire.com/news-releases/mitsubishi-tanabe-pharma-america-announces-fda-approval-of-radicava-ors-edaravone-for-the-treatment-of-als-301546937.html
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