Dawnzera is designed to inhibit plasma prekallikrein, a significant activator of the inflammatory mediators that cause acute HAE attacks. This 80mg dose of the medicine is self-administered through a ...

The US Food and Drug Administration (FDA) has approved Dawnzera (donidalorsen) for prophylaxis to prevent attacks of ...

Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) announced today that the U.S. Food and Drug Administration (FDA) has approved ...

The approval makes donidalorsen the only treatment in the US for hereditary angioedema that is an RNA-targeted prophylactic.

Dawnzera, a prekallikrein-directed antisense oligonucleotide, is supplied as a 80mg/0.8mL solution in a single-dose autoinjector.

Developed by Ionis Pharmaceuticals, Dawnzera is the first RNA-targeted medicine approved for HAE, designed to target plasma ...

Ionis Pharmaceuticals, Inc. today announced that positive results from the Phase 3 OASISplus prospective switch study of donidalorsen in patients with hereditary angioedema were published in The ...

Donidalorsen was effective in improving disease control and quality of life measures in patients with hereditary angioedema. Over 2-month dosing, the drug showed a continued attack rate reduction.

Trading in shares of Ionis Pharmaceuticals is halted Thursday ahead of an expected decision from the U.S. Food and Drug Administration on the company's proposed donidalorsen treatment for hereditary ...

Ionis looks forward to reporting topline Phase 3 donidalorsen results in HAE in 1H of 2024. Ionis will receive a $65 million upfront payment, milestone payments, and sales-based royalties ranging ...

– Donidalorsen is currently under review with the U.S. FDA as a potential first-in-class prophylactic treatment for HAE; PDUFA date August 21 – Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) today ...

In June, the monoclonal antibody garadacimab (Andembry) was approved for prevention of HAE attacks at a dose of once monthly ...