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 ...

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

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

By Sneha S K and Bageshri Banerjee (Reuters) -The U.S. Food and Drug Administration on Thursday approved Ionis ...

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 ...

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 ...

Dawnzera is the third medicine cleared by U.S. regulators this year for the rare genetic condition, and the second wholly owned medicine Ionis has brought to market.

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.

– 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 ...