Atsushi “Andy” Fujimoto, Mitsubishi Tanabe Pharma America president

FDA ap­proves oral for­mu­la­tion of old ALS drug, giv­ing pa­tients new treat­ment op­tion in sore­ly need­ed field

Much of the ALS drug news in re­cent months has fo­cused on Amy­lyx Phar­ma­ceu­ti­cals and its ex­per­i­men­tal pro­gram re­viewed by an FDA ad­vi­so­ry com­mit­tee in March. But on Thurs­day, the FDA green­light­ed a new way to take an al­ready-ap­proved ALS drug that flew un­der the radar.

US reg­u­la­tors OK’ed an oral for­mu­la­tion of Rad­i­ca­va, first ap­proved to treat ALS back in 2017 as a se­ries of IV in­fu­sions, to treat adults with ALS, the agency an­nounced Thurs­day af­ter­noon. The de­ci­sion gives pa­tients an­oth­er op­tion for a uni­ver­sal­ly fa­tal dis­ease with on­ly one oth­er ap­proved drug.

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