US regulators are undertaking a speedy review of Shire’s lanadelumab (SHP643) for the prevention of angioedema attacks in patients 12 years and older with hereditary angioedema (HAE).
HAE is a rare, genetic disorder that causes debilitating, painful and sometimes life-threatening swelling in the body.
Shire’s application for lanadelumab, an investigational fully human monoclonal antibody that specifically binds and inhibits plasma kallikrein, is supported by data from four clinical trials.
Data from the pivotal Phase III HELP study showed that subcutaneous administration of 300mg lanadelumab once every two weeks resulted in an 87 percent reduction in the mean frequency of HAE attacks.
In addition, an exploratory endpoint, which will require further confirmatory studies, showed that during the steady state stage of the trial (day 70-182) a 91 percent attack reduction was achieved with eight out of 10 patients reaching an attack free state.
In this study, no treatment-related serious adverse events or deaths were reported, the most common side effecting observed being injection site pain (29.3 percent placebo vs. 42.9 percent across lanadelumab arms).
"Physicians as well as patients in the HAE community are excited to see lanadelumab moving forward for FDA review because there is now the real possibility of having a new way to prevent HAE attacks," said Aleena Banerji, Massachusetts General Hospital, Boston, MA, and clinical trial investigator.
The US Food and Drug Administration has granted the application a priority review, signaling its belief that the drug has the potential to provide a significant treatment benefit to patients. As such, the regulator’s assessment should be completed within eight months as opposed to 12 months, meaning that a decision is due by August 26.