- The positive recommendation is based on P-III Help Study Open-label Extension assessing Takhzyro (300mg, q2w) in 212 HAE adolescents and adults aged ≥12 yrs.
- The P-III Help study OLE results: reduction rate of attacks, reduction in attacks requiring acute treatment (92.6%), reduction in mod. to sev. attacks (83.6%), mean attack rate (87%); 58% & 78% patients showed maximum attack-free period lasted ≥12mos. & ≥6mos. following the first regular treatment dose respectively
- Takhzyro is a mAb targeting plasma kallikrein activity, indicated for the routine prevention of HAE attacks in patients aged ≥12 yrs. and is an approved therapy in multiple countries including the US, EU, Australia and Switzerland with additional ongoing regulatory submission across the globe
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