Shire’s Takhzyro (lanadelumab-flyo) Receives FDA Approval Novel Hereditary Angioedema (HAE) in Age ≥12yrs
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