Shire: FDA Approves TAKHZYRO Injection

(RTTNews) - Shire plc (SHPG) announced that FDA has approved TAKHZYRO (lanadelumab-flyo) injection, for prophylaxis to prevent attacks of hereditary angioedema (HAE) in patients 12 years of age and older.

HAE is a rare, genetic and potentially life-threatening disorder that can result in recurrent attacks of edema (swelling) in various parts of the body.

In the pivotal study, patients taking TAKHZYRO 300 mg every 2 weeks had an 87% reduction in mean monthly attacks vs. placebo (0.26 vs. 1.97, n=27 vs. n=41)

Overall, each TAKHZYRO treatment arm demonstrated statistically significant attack rate reductions compared with placebo for all secondary efficacy endpoints and included reduction in moderate or severe attacks and attacks requiring acute treatment, the company stated.

According to an exploratory endpoint, there were patients receiving TAKHZYRO 300 mg every 2 weeks who had zero attacks during the study.