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Ionis Poised To Build Out Commercial Portfolio With Donidalorsen Success

 
• By Jessica Merrill

A Phase III study testing the ligand-conjugated anti-sense medicine in hereditary angioedema read out positively, but the drug would join a competitive market if approved.

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Ionis has had sequential positive data read outs • Source: Shutterstock

Ionis Pharmaceuticals, Inc. is on track for back-to-back drug launches after announcing positive Phase III data on its ligand-conjugated anti-sense (LICA) medicine donidalorsen as a prophylactic treatment for hereditary angioedema (HAE), which Ionis could submit for US Food and Drug Administration approval soon after it submits olezarsen for familial chylomicronemia syndrome (FCS).

The company announced positive data from the Phase III OASIS-HAE study of donidalorsen on 22 January and said it is preparing to file for approval

Key Takeaways
  • A Phase III trial testing donidalorsen as a prophylactic treatment for hereditary angioedema (HAE) could support regulatory filings.
  • HAE is a competitive market but donidalorsen could offer an efficacy and dosing advantage, though detailed data will be needed to understand the competitive profile

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