Takhzyro Wins Prix Galien Canada as 2022’s Best Innovative Product

HAE preventive therapy chosen for 'significant contribution to patient care'

Teresa Carvalho, MS avatar

by Teresa Carvalho, MS |

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Takhzyro (lanadelumab), an under-the skin injection therapy to prevent attacks in people with hereditary angioedema (HAE), has won the 2022 Prix Galien Canada Innovative Product Award.

The prestigious annual award is given to a company — here, Takeda Pharmaceuticals — in recognition of a marketed product that has “made the most significant overall contribution to patient care in Canada in terms of efficacy, safety, benefits and innovation,”  Prix Galien Canada reported on a webpage.

An approved treatment of HAE swelling attacks in adults and children, Takhzyro was selected by a panel of eight academic and industry members, all with experience in pharmaceutical research in Canada.

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Takhzyro lowers bradykinin levels by blocking the kallikrein protein

“We are honoured Takhzyro has received the Prix Galien Canada 2022 Innovative Product Award, and are even more proud of the tremendous impact it’s had on HAE patients in Canada,” Rute Fernandes, general manager of Takeda Canada, said in a press release.

“This prestigious award is a reflection of Takeda’s dedication and commitment to bring innovative treatments to patients,” Fernandes said.

Originally developed by Shire, now part of Takeda, Takhzyro is a human monoclonal antibody that blocks a protein called kallikrein. By blocking kallikrein, Takhzyro works to lower levels of the pro-inflammatory molecule bradykinin, produced in excessive amounts in people with HAE, and decrease the likelihood of swelling attacks.

Its recommended starting dose is 300 mg every two weeks. If patients remain free of attacks for more than six months and have a low body weight, dosing every four weeks may be considered.

Takhzyro, approved in Canada in 2018, is also available as a preventive treatment for HAE attacks in the U.S., Europe, Australia, and China, in patients ages 12 and older, with types 1 and 2 HAE. In some countries, the medication also is available in the form of a prefilled syringe.

The U.S. Food and Drug Administration (FDA) has accepted for review a Takeda request, supported by findings in the open-label SPRING study (NCT04070326), to extend Takhzyro’s approval to children with HAE starting at age 2. An FDA decision is expected in the first half of 2023.

SPRING trial results, reported over the summer, found 16 of its 21 patients, ages 2 to 11, free of swelling attacks over one year of treatment and an overall drop of 94.8% in attack rates.