Lanadelumab to prevent HAE attacksOctober 10, 2018
Following priority review, the US FDA has approved lanadelumab-flyo (Takhzyro) injection, for prophylaxis to prevent attacks of hereditary angioedema (HAE) in patients 12 years of age and older, Shire plc said.
Lanadelumab is a monoclonal antibody that provides targeted inhibition of plasma kallikrein, an enzyme which is chronically uncontrolled in people with HAE, to help prevent attacks. The recommended starting dose of lanadelumab is 300 mg every two weeks. A dosing interval of 300 mg every four weeks is also effective and may be considered if the patient is attack free for more than six months.
The FDA approval of lanadelumab was based on data from four clinical trials, including the HELP (Hereditary Angioedema Long-term Prophylaxis) Study, the largest prevention study conducted to date in HAE, according to Shire.
In the Phase III HELP study, lanadelumab reduced the number of monthly HAE attacks an average of 87% (n=27) vs. placebo (n=41) when administered at 300 mg every two weeks and 73% (n=29) vs placebo (n=41) when administered at 300 mg every four weeks.
Lanadelumab has a half-life of approximately two weeks and is administered as one subcutaneous self-injection every two weeks at the recommended starting dose.
Shire added lanadelumab to its HAE portfolio with the acquisition of Dyax Corp.