The FDA recently approved a new sub-q therapy, Dawnzera (donidalorsen) from Ionis Pharmaceuticals, Inc. indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients 12 years of age and older. Dawnzera is the first and only RNA-targeted medicine approved for HAE, designed to target plasma prekallikrein (PKK), a key protein that activates inflammatory mediators associated with acute attacks of HAE. Dawnzera was designed to target plasma prekallikrein, a protein that activates inflammatory mediators associated with acute attacks of HAE.
Dawnzera represents a first-in-class therapy for hereditary angioedema (HAE), offering a new approach to disease management. This subcutaneous treatment is designed to be self-administered, providing greater convenience for patients. According to Ionis, Dawnzera’s ease of use and self-administration make it a preferred prophylactic option for many individuals living with HAE.
Dawnzera has demonstrated the ability to reduce sudden and often unpredictable flareups that characterize HAE of severe swelling affecting the limbs, the face and other bodily areas. HAE affects 7,000 people in the U.S. and can be fatal resulting from restricted airways.
It is reported that the cost of Dawnzera will be $57,462 per dose or $747,000 annually based on the maximum dosing (q4 week) schedule.
Dawnzera will be available through specialty pharmacy distribution. Orsini Specialty Pharmacy has been selected as the exclusive SP partner for Dawnzera.
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DAWNZERA (donidalorsen) approved in the U.S. as first and only RNA-targeted prophylactic treatment for hereditary angioedema
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