Lanadelumab-flyo is a fully human recombinant nonplasma-derived monoclonal antibody created in recombinant Chinese hamster ovary cells, and it inhibits plasma kallikrein.

Plasma kallikrein is a protease that splits high-molecular–weight kininogen to produce a cleaved high-molecular–weight kininogen and bradykinin.

The inhibition of plasma kallikrein reduces excess bradykinin production in patients with hereditary angioneurotic edema.

Bradykinin acts as a vasodilator that increases vascular permeability, leading to the characteristic HAE swelling and pain.

Lanadelumab-flyo provides concentration-dependent inhibition of plasma kallikrein and is dose proportional in the therapeutic dose range after subcutaneous administration.

The elimination half-life is reached in 14 days, with peak plasma concentrations achieved at 5 days.

The steady state concentrations are achieved at 70 days.

Lanadelumab-flyo’s suggested starting dose is 300 mg every 2 weeks. In well-controlled or attack-free patients, for at least 6 months, an extended dosing interval of 300 mg every 4 weeks may be more appropriate for some patients.

No dosage adjustments are required for renal impairment.

Lanadelumab-flyo should be used as a long-acting prophylaxis for hereditary angioneurotic edema treatment, while existing medications should be reserved for acute attack on-demand treatment.

Patients in the lanadelumab-flyo treatment arms showed clinically meaningful and statistically significant drops in HAE attack rates: Compared with the placebo group, the 3 lanadelumab-flyo treatment arms reduced the number of HAE attacks by 76%, 73%, and 87%,

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