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DAWNZERA™ approved in the U.S. as first and only RNA-targeted prophylactic treatment for hereditary angioedema
_↗ ir.ionis.com
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The U.S. Food and Drug Administration (FDA) has approved DAWNZERA (donidalorsen), a new RNA-targeted medicine for the prophylactic prevention of hereditary angioedema (HAE) attacks in patients 12 years and older, as announced by Ionis Pharmaceuticals.

The approval is based on the positive results from the Phase 3 OASIS-HAE study, which showed that DAWNZERA significantly reduced the monthly HAE attack rate by 81% compared to a placebo. This reduction increased to 87% from the second dose onward. The ongoing OASISplus open-label extension study further demonstrated sustained long-term disease control, with a 94% total mean attack rate reduction after one year. A separate "switch cohort" study also found that patients who switched to DAWNZERA from other prophylactic treatments experienced a 62% reduction in their mean HAE attack rate.

DAWNZERA has a favorable safety and tolerability profile, with the most common side effects being injection site reactions, upper respiratory tract infection, urinary tract infection, and abdominal discomfort. The approval is a significant advancement for HAE patients, providing a new, convenient treatment option with strong, durable efficacy. Ionis will also offer a suite of patient support services called Ionis Every Step™ to help patients access the new medication and manage their treatment.

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