Mitsubishi Tanabe Pharma Corporation tries to get approval for commercializing oral formulation of edaravone

For amyotrophic lateral sclerosis, Mitsubishi Tanabe Pharma Corporation (MTPC) is awaiting permission to produce and commercialise MT-1186. It is an oral formulation of edaravone (ALS).

In the United States, a comparable application recently received priority review, reducing the regulatory review period from the typical 10 months to six months. In May, a final judgement is likely.

Edaravone is intended to reduce oxidative stress, which is suspected to contribute to nerve cell death in ALS. Oxidative stress is defined as an imbalance between the generation of potentially damaging free radicals and the antioxidants needed to detoxify them.

The drug is now available in an into-the-vein formulation produced by Mitsubishi Tanabe and sold in the United States as Radicava and Japan as Radicut.

Radicava has been demonstrated to reduce disease progression in ALS research studies, but it needs 10 days of hour-long infusions per month, requiring patients to spend a large amount of time in a clinic.

MT-1186 is an oral formulation that has a clinical profile comparable to Radicava but is more convenient and less stressful for patients.

The medication was studied in 185 persons with ALS who developed symptoms within three years after enrolment in an open-label Phase 3 study (NCT04165824). For 48 weeks, patients were given 105 mg of the treatment in the same dosage schedule as Radicava (nearly one year).

After around six months of therapy, interim data showed that MT-1186 was typically safe and well-tolerated. The treatment may also delay functional deterioration to a degree similar to that reported in the Phase 3 Study 19 trial of Radicava, according to preliminary findings (NCT01492686).

Those who successfully completed the Phase 3 study may be eligible to participate in an open-label extension experiment (NCT04577404), in which they will all receive MT-1186 for 96 weeks (nearly two years). The primary objective is to determine the therapy’s long-term safety and tolerability, although exploratory effectiveness measures will be evaluated as well.

A Phase 3b study (NCT04569084) is in underway to compare the safety and effectiveness of two oral edaravone dose regimens versus a placebo. Participants are being sought in 91 sites across the United States and Canada.

The major goal of the study is to see how the ALS Functional Rating Scale Revised scores evolve over time. Changes in lung function and general health, as well as the time to death, tracheostomy (a tube put into the neck to aid breathing), and ventilatory assistance, are all secondary metrics.

The MTPC Group remarked, “MTPC Group will continue to work relentlessly to deliver fast access to novel treatment choices that decrease the burden of ALS patients.”

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