Shire says it presented data showing that its experimental drug lanadelumab provides a significant and clinically meaningful reduction of hereditary angioedema (HAE) attacks.
The firm is developing lanadelumab for the prevention of angioedema attacks in patients with the condition aged 12 years and older.
HAE is a rare, genetic disorder that causes debilitating, painful and sometimes life-threatening swelling in the body, affecting about one in 10,000 to one in 50,000 people worldwide.
Lanadelumab is an investigational fully human monoclonal antibody that specifically binds and inhibits plasma kallikrein, thus potentially offering a new treatment approach.
According to Shire, data from the HELP study showed that patients treated with lanadelumab 300mg every two weeks experienced significantly fewer HAE attacks, were less likely to have moderate or severe attacks or use rescue medication (primary and secondary endpoints), and were more likely to be HAE attack-free than those treated with placebo.
“For those living with this chronic and unpredictable disease, it is important that they can reduce the frequency of their HAE attacks. Additional analysis of the HELP Study continues to support the use of lanadelumab as a preventive subcutaneous treatment option for HAE in appropriate patients 12 years of age and older,” said Shire’s head of research and development, Andreas Busch.
Lanadelumab was filed in Europe in March this year based on data from the pivotal Phase III HELP study, which showed that subcutaneous administration of 300mg lanadelumab once every two weeks resulted in an 87% reduction in the mean frequency of HAE attacks.