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FDA Approves Ionis’ Dawnzera to Prevent Hereditary Angioedema Attacks

The RNA therapy offers self-injected dosing every four or eight weeks with strong Phase III reductions in attack rates.

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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

  • Dawnzera (donidalorsen) is cleared to prevent hereditary angioedema attacks in patients aged 12 years and older.
  • The antisense RNA drug lowers plasma prekallikrein and is given as an 80 mg subcutaneous autoinjector on four- or eight-week schedules.
  • In the Phase III OASIS-HAE study, four-week dosing reduced monthly attacks by 81% versus placebo, while every-other-month dosing cut attacks by 55%.
  • Open-label extension results showed eight-week dosing achieved similar outcomes to four-week injections over time, including a 94% mean reduction in attacks at one year.
  • Ionis will commercialize the medicine itself in a competitive HAE market that added Ekterly and Andembry this year, with pricing to be announced by the company.