The odds that Amylyx Prescribed drugs wins approval from the Meals and Drug Administration for Albrioza, its remedy for ALS, have elevated considerably over the previous two weeks. My prediction: The FDA grants accelerated approval to Albrioza, with the requirement that Amylyx affirm the drug’s profit for sufferers with outcomes from the continued Section 3 research — knowledge anticipated in 2024.
I’m able to making a constructive prediction sometimes. I’m not all doom and gloom. This one feels proper, with echoes of how the FDA acted on eteplirsen, the Duchenne muscular dystrophy drug, in 2016, and extra not too long ago, Biogen’s Alzheimer’s remedy Aduhelm, in 2021.