Swiss regulators approve Andembry for HAE patients ages 12 and older
Monthly preventive treatment works to lower frequency of swelling attacks
Andembry (garadacimab) is approved in Switzerland as a prophylactic (preventive) treatment to lower the frequency of recurrent swelling attacks in people with hereditary angioedema (HAE), ages 12 and older.
The decision by the Swiss Agency for Therapeutic Products marks the fifth regulatory approval of Andembry for HAE, following similar actions in the European Union, the U.K., Australia, and Japan. The therapy’s developer, CSL Behring, also is seeking the therapy’s approval in the U.S.; that application is still under review.
“We are incredibly proud of these milestones, which reflect our decades-long commitment to delivering innovative medicines to the HAE community,” Emmanuelle Lecomte-Brisset, global head of regulatory affairs at CSL, said in a company press release. “Access and reimbursement negotiations are currently underway to ensure that Andembry is made available to eligible people with HAE in Switzerland.”
Andembry lowered swelling attacks by more than 85% in Phase 3 trial
HAE is a genetic disorder characterized by recurrent swelling attacks driven by the excessive production of a signaling molecule called bradykinin. Andembry is an antibody-based treatment that works to reduce bradykinin levels by blocking the activated form of factor XII (FXII), a protein that’s involved in the cascade of events leading up to the bradykinin production. By lowering bradykinin levels, the therapy is designed to reduce the frequency of swelling attacks.
Andembry is first once-monthly HAE prophylactic treatment targeting activated FXII to be available in Switzerland.
“While there are current treatments available for HAE, individual needs and responses to treatment vary,” said Michael Haslauer, country medical lead for Switzerland at CSL. “Andembry offers people living with HAE a vital new treatment option that provides long-term control over their disease.”
Andembry’s approval was supported by data from the Phase 3 VANGUARD (NCT04656418) trial that tested the therapy against a placebo in more than 60 people with HAE, ages 12 and older. Results showed that, relative to placebo, Andembry was able to reduce the rates of swelling attacks by more than 85%.
Most patients who completed VANGUARD joined others in an ongoing and long-term extension study (NCT04739059). Available data consistently suggest that Andembry helps to prevent swelling attacks.
A separate Phase 3 trial (NCT05819775) is testing Andembry in children with HAE, ages 2-11, with results expected in 2026.
CSL’s Berinert (human C1 esterase inhibitor) for on-demand treatment of HAE also approved in Switzerland in its intravenous (into-the-vein) and subcutaneous (under-the-skin) formulations.
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