Health Canada approves Andembry to prevent swelling attacks
Therapy already OK'd in US, UK, EU, Australia, Japan, and Switzerland
A monthly injection therapy developed by CSL Behring has won approval from Health Canada to prevent swelling attacks in people with hereditary angioedema (HAE), ages 12 and older.
The approval of Andembry (garadacimab-gxii) follows approvals this year in the U.S., the European Union, the U.K., Australia, Japan, and Switzerland.
“This approval marks a major step forward in HAE care, building on our more than 40-year legacy in HAE research and treatment optimization to offer people living with this life-threatening condition long-term control over their disease along with a convenient administration method,” Bill Mezzanotte, MD, executive vice president and head of research and development at CSL, said in a company press release.
HAE advocates in Canada also welcomed Andembry’s approval.
“We are pleased to see Health Canada’s authorization of Andembry for HAE and look forward to its availability in Canada,” said Michelle Cooper, president of HAE Canada.
Stephen Betschel, MD, chairman of the Canadian Hereditary Angioedema Network, an HAE-focused physician group, said the approval “represents a significant advancement in the treatment of HAE.” “Having a new treatment option will further enhance our ability to help our patients manage their HAE effectively.”
How does Andembry work to prevent swelling attacks?
HAE is a genetic condition characterized by bouts of swelling. Andembry works to block the activity of activated factor XII (FXIIa), a clotting protein that triggers the cascade of events that lead to swelling. The therapy is given via monthly injections under the skin and can be self-administered.
“This new therapy, which targets factor XIIa, offers a promising approach to preventing HAE attacks. By addressing the underlying mechanisms of HAE, Andembry provides an important option for patients to reduce the frequency of their attacks of angioedema,” Betschel said.
Andembry’s approvals are based on data from a Phase 3 trial called VANGUARD (NCT04656418), which tested it against a placebo in 64 adults and adolescents with HAE types 1 or 2. The results showed the monthly attack rate was nearly 90% lower with Andembry than with a placebo. Over six months, most Andembry-treated patients had no attacks at all, whereas every person on a placebo had at least one. The most common side effects included headache, abdominal pain, and injection site reactions such as bruising, redness, or itching.
“As the first treatment to target the top of the HAE cascade, this therapy represents a significant advancement in preventing HAE attacks,” Cooper said. “We believe it will provide meaningful benefits to the HAE community in Canada.”
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