Shire announced that the Food and Drug Administration (FDA) has approved Takhzyro (lanadelumab-flyo) for prophylaxis to prevent attacks of hereditary angioedema (HAE) in patients aged ≥12 years. 

Takhzyro is a first-of-its-kind fully human IgG1 monoclonal antibody (mAb) that specifically binds plasma kallikrein and inhibits its proteolytic activity. In patients with HAE due to C1-inhibitor deficiency or dysfunction, normal regulation of plasma kallikrein activity is not present, which leads to uncontrolled increases in plasma kallikrein activity and results in angioedema attacks. Lanadelumab-flyo decreases plasma kallikrein activity to control excess bradykinin generation in patients with HAE.

The approval was based on data from 4 clinical trials, including the 26-week Phase 3 HELP (Hereditary Angioedema Long-Term Prophylaxis) study that enrolled 125 patients with HAE aged ≥12 years. The primary endpoint was the number of investigator-confirmed HAE attacks over the 26-week study duration. 

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The data showed treatment with Takhzyro 300mg every 2 weeks decreased the number of monthly HAE attacks by 87% vs placebo (P <.001). Treatment with Takhzyro 300mg every 4 weeks decreased the number of monthly HAE attacks by 73% vs placebo. Moreover, the study arm that received Takhzyro every 2 weeks experienced 83% fewer moderate to severe attacks and 87% fewer attacks that required on-demand treatment. 

Findings from a pre-specified, exploratory analysis found that 44% of Takhzyro-treated patients (300mg every 2 weeks) were attack-free vs placebo (2%) during the 26-week treatment period from Day 0 to 182. Also, a post-hoc analysis of Day 70 to 182 data showed that 77% of Takhzyro-treated patients were attack-free vs placebo (3%). 

The most common adverse reactions reported were injection site reactions, upper respiratory infections, headache, rash, muscle pain, dizziness, and diarrhea.

Takhzyro will be supplied as a 300mg/2mL (150mg/mL) strength solution for subcutaneous injection in single-dose vials. 

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