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Amylyx Plans FDA Filing After GLP-1 Drug Hits Trial Goals in Rare Metabolic Condition
Amylyx said the once-daily injection was well-tolerated and plans a U.S. approval filing by year-end after no approved treatments exist.
- Shares of Amylyx Pharmaceuticals surged Tuesday after the company announced its investigational drug avexitide reduced low blood sugar episodes by 55% in a late-stage Phase 3 trial.
- Post-Bariatric hypoglycemia affects about 8% of the 160,000 people in the United States who underwent weight-loss surgery, yet there are currently no FDA-approved therapies for this condition.
- In the 78-patient, 16-week study, avexitide blocked GLP-1 receptors to stabilize blood glucose levels while proving generally well-tolerated with no serious adverse events.
- Amylyx intends to file a New Drug Application with the FDA by year-end, while Cowen analysts project peak U.S. sales of $1.5 billion for avexitide.
- Chief medical officer Camille Bedrosian called the results a "major milestone" demonstrating avexitide's potential to address the critical treatment gap for the PBH community.
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13 Articles
Amylyx Plans FDA Filing After GLP-1 Drug Hits Trial Goals in Rare Metabolic Condition
Amylyx Pharmaceuticals’ avexitide led to statistically significant and clinically meaningful reductions in hypoglycemic events in patients with post-bariatric hypoglycemia (PBH). This peptide drug, a GLP-1 antagonist, was acquired from Eiger BioPharmaceuticals in 2024.
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Leaning Left1Leaning Right3Center4Last UpdatedBias Distribution50% Center
Bias Distribution
- 50% of the sources are Center
50% Center
13%
C 50%
R 37%
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