Joshua Cohen (L) and Justin Klee, Amylyx co-CEOs

Up­dat­ed: Af­ter long and wind­ing road, FDA ap­proves Amy­lyx's ALS drug in vic­to­ry for pa­tients and ad­vo­ca­cy groups

For just the third time in its 116-year his­to­ry, the FDA has ap­proved a new treat­ment for Lou Gehrig’s dis­ease, or ALS.

US reg­u­la­tors gave the thumbs-up to the drug, known as Re­lyvrio, in a mas­sive win for pa­tients and their fam­i­lies. The ap­proval, giv­en to Boston-area biotech Amy­lyx Phar­ma­ceu­ti­cals, comes af­ter two years of long and con­tentious de­bates over the drug’s ef­fec­tive­ness be­tween ad­vo­ca­cy groups and FDA sci­en­tists, fol­low­ing the read­out of a mid-stage clin­i­cal tri­al in Sep­tem­ber 2020.

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