Health Canada approves Dawnzera (donidalorsen) to prevent hereditary angioedema attacks

Health Canada has approved Dawnzera (donidalorsen) for preventing attacks of hereditary angioedema (HAE) in adults and adolescents aged 12 and older, adding a new long-term option for a rare, potentially life-threatening swelling disorder.

In a Sept. 30 Celystra Pharma newswire release, the Québec-based company said Dawnzera is an RNA-targeted medicine designed to reduce production of plasma prekallikrein, a protein linked to inflammatory pathways that drive HAE attacks. HAE is estimated to affect about 1 in 50,000 people and causes unpredictable swelling in areas including the hands, feet, abdomen, face and throat. Dawnzera 80 mg is self-administered by subcutaneous injection every four or eight weeks via a single-dose pre-filled autoinjector and is not intended for treating acute attacks. Approval rested on the pivotal OASIS-HAE Phase 3 trial and its OASISplus open-label extension: every-four-week dosing cut the monthly attack rate by 81 per cent versus placebo over 24 weeks, with an 87 per cent reduction from the second dose and about a 90 per cent drop in moderate-to-severe attacks from the second dose. After one year in the extension, mean attack rates fell 94 per cent from baseline across dosing groups; patients who switched from other prophylactics saw a further 62 per cent mean monthly reduction, and 84 per cent of surveyed switchers preferred donidalorsen.

Angioedema News noted prior U.S. and European Union approvals for the same indication and said Celystra, which licensed Canadian rights from Ionis Pharmaceuticals, expects commercial availability in Canada in the coming months while pursuing reimbursement reviews with Canada’s Drug Agency and Québec’s INESSS. Dr. Stephen Betschel of Unity Health’s St. Michael’s Hospital and chair of the Canadian Hereditary Angioedema Network called prevention central to HAE care and welcomed another option for clinicians and patients.

This article is for information only and is not a substitute for professional medical advice. Consult a qualified clinician for personal health decisions.

Sources: Celystra Pharma / CNW newswire; Angioedema News.