DATA GRAPHICS | Regulation
CHMP departs from FDA again in neuro, with Amylyx’ ALS therapy
CHMP’s June opinions: Amylyx therapy denied, plus positive opinions for two new medicines and eight label extensions
June 23, 2023 11:14 PM UTC
Once again, EMA’s CHMP has viewed the data for a neurodegeneration therapy differently than FDA, recommending against approval of Amylyx’s ALS therapy.
Albrioza, a fixed dose combination of sodium phenylbutyrate and ursodoxicoltaurine, has full approval in the U.S. and conditional approval in Canada to treat amyotrophic lateral sclerosis. Unless CHMP’s recommendation changes in the appeal that Amylyx Pharmaceuticals Inc. (NASDAQ:AMLX) said it will file, the drug is unlikely to be approved in the EU...
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