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4mo ago

FDA Approves Ionis’ Dawnzera to Prevent Hereditary Angioedema Attacks

The RNA-targeting antisense shot lowers plasma prekallikrein, delivering large attack-rate reductions with four- or eight-week autoinjector dosing.

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The 80mg dose of Dawnzera is self-administered through a subcutaneous autoinjector. Credit: Ionis Pharmaceuticals, Inc./Business Wire.
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Overview

  • Ionis’ therapy is cleared for prophylaxis in patients aged 12 years and older.
  • The approved presentation is an 80 mg subcutaneous autoinjector administered every four or eight weeks.
  • In the Phase III OASIS-HAE trial, monthly attacks fell 81% with four-week dosing versus placebo, with a 55% reduction observed using every-other-month dosing.
  • Trial reports noted common side effects including injection-site reactions, urinary and upper respiratory tract infections, and abdominal discomfort.
  • The launch enters a crowded HAE market that added Ekterly and Andembry this year, while Ionis plans to market Dawnzera itself and previously said it would disclose pricing on a company call.