CELYSTRA’s Dawnzera Approved in Canada for Hereditary Angioedema
CELYSTRA Pharma announced that Health Canada has approved Dawnzera (donidalorsen) to prevent hereditary angioedema (HAE) attacks in adults and pediatric patients aged 12 years and older. The RNA-targeted therapy reduces plasma prekallikrein production and is self-administered subcutaneously at 80 mg once every four or eight weeks. In the Phase 3 OASIS-HAE study, Dawnzera administered every four weeks reduced monthly HAE attack rates by 81% versus placebo over 24 weeks, with an 87% reduction from the second dose. CELYSTRA has initiated reimbursement reviews with CDA and INESSS, with commercial availability in Canada expected in the coming months.
Nemluvio Moves Closer to Public Reimbursement in Canada
Galderma completed pCPA negotiations for Nemluvio (nemolizumab), advancing access for patients aged 12 years and older with moderate-to-severe atopic dermatitis and adults with moderate-to-severe prurigo nodularis inadequately controlled with topical therapies. Nemluvio is the first approved monoclonal antibody targeting the IL-31 receptor alpha, blocking IL-31 signaling involved in itch, inflammation, skin-barrier dysfunction in atopic dermatitis, and fibrosis in prurigo nodularis. The milestone follows CDA-AMC’s March 2026 recommendation to reimburse Nemluvio with conditions and a positive INESSS indication for prurigo nodularis in February 2026. Galderma will continue working with public drug plans and the dermatology community as the reimbursement process progresses.
Nduvra Approved in Canada for Moderate to Severe Atopic Dermatitis
Organon announced that Health Canada has approved Nduvra (tapinarof cream) 1% for the topical treatment of moderate to severe atopic dermatitis in adults and pediatric patients aged 2 years and older, with the treatment now available in Canada. Nduvra is a topical aryl hydrocarbon receptor agonist that provides a non-steroidal treatment option and can be prescribed by family physicians without specialist referral. The approval builds on tapinarof’s Canadian research history, including its discovery in Canada and clinical development involving Canadian study sites. It marks the drug’s second approved indication in Canada following its 2025 approval for plaque psoriasis in adults.
