Takhzyro, for HAE Attacks, Moves Closer to Public Funding Across Canada

Takeda Canada announced reaching an agreement for public funding in Canada of Takhzyro (lanadelumab), its treatment for eligible hereditary angioedema (HAE) patients.

The agreement was reached between the company and the pan-Canadian Pharmaceutical Alliance, the agency responsible for setting the prices of brand and generic medications available throughout Canada. The agreed price was not disclosed.

Takeda will now begin working with relevant agencies across the country’s provinces and territories  “to ensure equitable and timely access” to treatment, it stated in a press release.

“Takhzyro has the potential to transform care for patients and as a physician who treats this chronic condition, I hope to see rapid access for patients who can benefit from this important treatment option,” said Stephen D. Betschel, MD, chair of The Canadian Hereditary Angioedema Network.

Takhzyro is a monoclonal antibody directed against a protein called kallikrein. Kallikrein activates another protein called bradykinin, which when produced in excess causes fluid to accumulate in patient tissues, leading to attacks of HAE. By blocking kallikrein, Takhzyro reduces the likelihood of these swelling attacks.

In the HELP Phase 3 clinical trial (NCT02586805), preventive treatment with Takhzyro significantly reduced the number of monthly attacks and attacks requiring acute treatment compared with placebo. Approximately 44% of patients receiving 300 mg of Takhzyro every two weeks remained attack-free throughout the trial, as did 2.4% of those given a placebo.

An analysis conducted after the trial also showed that once the medicine reached a steady state in patients’ blood (around day 70), the proportion of those free of attacks grew to nearly 77%, compared with 3% in the placebo group.

Takhzyro was approved by Health Canada  for the routine prevention of HAE attacks in patients ages 12 and older in 2018, following a priority review. It was recommended for reimbursement by public health plans the following year.

“With the Letter of Intent in place, this lays the path forward for funding discussions with each of the participating jurisdictions, and we look forward to working with our partners to bring this important therapy to Canadians living with HAE as soon as possible,” said Gamze Yüceland, general manager of Takeda Canada.

Each provincial and territorial government in Canada is responsible for the management, organization, and delivery of healthcare to its residents. The federal government largely sets national standards and provides financial support.

Takhzyro has been approved to prevent angioedema attacks in adolescents and adults with HAE in the U.S., the European Union, Australia, Switzerland, and Brazil, among other countries.

“Patients constantly live in fear of their next attack. They avoid social situations, even just going out in public, and this has a significant impact on their quality of life,” said Jacquie Badiou, president of Hereditary Angioedema Canada. “The HAE community is thrilled with this positive step forward, because having access to a treatment option that can prevent attacks would be life-changing.”