Shire's Takhzyro (lanadelumab-flyo) Receives FDA Approval Novel Hereditary Angioedema (HAE) in Age ≥12yrs
Shots:
- Approval is based on four clinical studies including P-III HELP (Hereditary Angioedema Long-term Prophylaxis) study (N=125) for 26 wks- administering Takhzyro 300mg Q2W- Q4W and 150 mg Q4W
- HELP results (Takhzyro vs PBO): No attack (44% vs 2%); 87% reduction in monthly attacks; post hoc (77% vs 3%) attack free; attacks requiring acute treatment (74% vs 87%-) and moderate or severe attacks (70% to 83%)
- Takhzyro receives Orphan drug designation. Shire acquired Takhzyro from Dyax in Jan’16 for $5.9B
/ | Ref: Shire| Image: EHSCareers
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