Amylyx picks up ALS drug approval in Canada after FDA asks for more time to review the data
Though the FDA earlier this month told Amylyx Pharmaceuticals the agency would need a little bit longer to review its ALS drug’s application, one country is forging ahead with a green light.
Canada approved Amylyx’s ALS drug AMX0035 early Monday morning, giving the biotech its first green light and ALS patients in the country only the third therapy available to treat the disease. The decision also marks a win for Amylyx, a one-drug biotech that went all-in on ALS — one of the most challenging diseases for drug R&D — and whose fortunes appeared murky after the FDA raised concerns over its data at an advisory committee meeting in March.
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