Shire’s Takhzyro (lanadelumab-flyo) Receives FDA Approval Novel Hereditary Angioedema (HAE) in Age ≥12yrs
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
Click here to read full press release/ article | Ref:Shire| Image:EHSCareers
Vartika Singh is a content writer who loves to write research articles and reports at PharmaShots. She has in-depth knowledge of the life sciences industry including the Pharma and Biotech sectors. Any articles written by her can be contacted at email@example.com.