Mitsubishi’s Oral Radicava Provides Convenience Option For ALS
Oral or feeding tube administration of the cerebral neuroprotectant should offer flexible dosing options for amyotrophic lateral sclerosis patients, the firm says.
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Medicare could be an important payer for the eagerly awaited drug because the program covers ALS treatments for patients under 65 as well as older ones. Meanwhile, a draft Institute for Clinical and Economic Review raises questions about the drug's cost effectiveness.
Amylyx’s AMX0035 and Mitsubishi’s edaravone showed similar treatment effect on ALS versus placebo in a single study, but the FDA found edaravone’s results to be more robust and supported by secondary endpoints.
Six of 10 advisory committee members say Phase II CENTAUR trial cannot stand on its own to support approval at this time. However, patients and advocates say thousands will die if they have to wait for the Phase III PHOENIX trial to complete in 2024 before the drug becomes widely available.