FDA Approves First in Class Therapy for Hereditary Angioedema

The FDA has approved Dawnzera (donidalorsen) to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients 12 years of age and older.

HAE is a rare genetic disorder caused by a dysfunction in the C1 esterase inhibitor (C1INH) protein, which is part of a group of proteins in the body’s immune system. As a result, periods of severe and sometimes deadly swelling can occur in the limbs, face, intestinal tract and airway. Episodes may be triggered by anxiety, medical procedures or illnesses such as colds or the flu, but often episodes are difficult to predict, according to the American Academy of Allergy, Asthma and Immunology.

"People living with HAE manage this condition for all their lives, and many continue to face unpredictable, painful and dangerous breakthrough at