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The US FDA has approved Ionis-AstraZeneca to treat rare nerve diseases. The US Food and Drug Administration approved Ionis Pharmaceuticals and partner AstraZeneca's drug to treat rare nerve diseases on Thursday.
This open-label, single-group, phase 3 trial evaluates eplontersen, an investigational ligand-conjugated antisense oligonucleotide, in adults with hereditary am
After a series of milestone approvals in the first half of 2023, the FDA is slated to decide on four more firsts before the year’s end.
The planned FDA submission follows the report from AstraZeneca and Ionis Pharmaceuticals that their partnered drug, eplontersen, met the main goals of a pivotal study in treating nerve pain caused by hereditary transthyretin-mediated amyloidosis. The data come one week after rival Alnylam Pharmaceuticals won FDA approval for its second drug for this rare disease.