The Biologics License Application (BLA) for lanadelumab (SHP643; Shire) – an investigational treatment for the prevention of hereditary angioedema (HAE) attacks – has been accepted by the Food and Drug Administration (FDA).

Lanadelumab, a fully human monoclonal antibody that specifically binds and inhibits plasma kallikrein, is intended for patients aged ≥12 years. If approved, it would be the first long-acting monoclonal antibody for HAE. The BLA submission is supported by data from the Phase 3 HELP study (N=125) and interim data from its extension study. 

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Results showed that those who received a subcutaneous (SC) administration of lanadelumab 300mg once every 2 weeks had an 87% reduction in mean frequency of HAE attacks. An exploratory endpoint further demonstrated a 91% attack reduction during the steady state stage (Days 70 to 182) of which 8/10 patients achieved an attack-free state. 

No treatment-related serious adverse events or deaths were noted during the trial, however there was a higher rate of injection site pain seen in the combined lanadelumab arms vs placebo (42.9% vs 29.3%).

The FDA Prescription Drug User Free Act (PDUFA) action date for a decision on lanadelumab has been set for August 26, 2018.

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