MHRA authorises donidalorsen for hereditary angioedema prevention

▤ Summary

The MHRA has authorised Dawnzera (donidalorsen) for routine prevention of hereditary angioedema attacks in adults and adolescents aged 12 and older. The approval follows results from the phase 3 OASIS-HAE trial, which showed an 81% reduction in attack rate with dosing every four weeks versus placebo. The article also notes that dosing every eight weeks reduced attack frequency and that most patients achieved well-controlled disease status. Safety findings included injection-site reactions, increased hepatic enzymes, and reported hypersensitivity reactions. Otsuka Pharmaceuticals UK plans to keep working with NICE and the NHS on patient access.

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