Takhzyro To Be Available at Lower Cost in Poland, Australia Likely as Well

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by Marisa Wexler MS |

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Takhzyro (lanadelumab), an approved under-the-skin injection therapy to prevent swelling attacks in people with hereditary angioedema (HAE), will soon be available at a lower cost to patients in Poland and, likely, those in Australia.

Poland’s Minister of Health approved access to and reimbursement for Takhzyro for about 50 patients, according to a statement from HAE Poland. The approval will be valid until Sept. 1, 2023, and HAE Poland is hopeful that approvals will be extended after that date.

The Minister of Health also extended reimbursement indications for another HAE treatment, Firazyr (icatibant injection), to cover pediatric patients. This means that from now on, children under age 18 with HAE in Poland will have access to Firazyr to treat their attacks.

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Separately, the Pharmaceuticals Benefit Advisory Committee in Australia has recommended that Takhzyro be listed on the country’s pharmaceuticals benefits scheme. The medication is expected to be officially listed by year’s end, which would also make it available to patients, according to a statement from HAE Australasia.

HAE Australasia also noted in its statement that it is working to conduct a survey on the socioeconomics and treatment of HAE patients in the country, similar to others conducted in the U.S. and Europe. The group is also organizing conferences for patients and caregivers in Australia and New Zealand.

An agreement for public funding of Takhzyro in Canada was reached late last year.

HAE is characterized by sudden bouts of swelling, which are driven by excess levels of a molecule called bradykinin. Takhzyro works by blocking the activity of another protein, called kallikrein, which controls bradykinin levels. By blocking kallikrein, Takhzyro can reduce bradykinin levels and, in doing so, lower the chances of swelling attacks.

The safety and efficacy of Takhzyro were evaluated in a Phase 3 trial, called HELP (NCT02586805). Results from the study showed that preventive treatment with Takhzyro was superior to a placebo at reducing the number of swelling attacks in HAE patients, even in the early phases of treatment.

Firazyr works by blocking the protein receptors that bradykinin normally binds to, so it cannot trigger swelling. It is used as an on-demand treatment of acute swelling attacks. Firazyr’s efficacy has been demonstrated in several clinical trials, including an open-label Phase 3 trial (NCT01386658) that tested the medicine in 32 children with HAE, and found it to be well-tolerated and effective at easing attack symptoms.

Both Firazyr and Takhzyro are marketed by Takeda Pharmaceuticals, with the company working alongside physicians and patient organization for more than 18 months to advocate for Takhzyro’s reimbursement in Poland.