’Takhzyro’ for HAE can be prescribed at the Big 5 tertiary gen hospitals

As of March, Takhzyro was added to the insurance reimbursement list, five years after obtaining approval

Clinical studies have shown that the absence of attacks is maintained for up to 2 years.5 years

Takhzyro

Takhzyro, a novel hereditary angioedema (HAE) therapy added to the reimbursement list after five years, is now available for prescription in general hospital prescription networks.

​According to industry sources, Takeda Korea's HAE treatment Takhzyro (lanadelumab) has cleared the Drug Committees (DCs) of major "Big 5" tertiary general hospitals, including Samsung Medical Center, Seoul National University Hospital, Asan Medical Center, and Seoul St. Mary's Hospital.

​In addition, the drug is now available for prescription at other major medical institutes, including Pusan National University Hospital, Ajou University Hospital, and Ewha Womans University Mokdong Hospital.

​Takhzyro was listed on the national health insurance reimbursement schedule this past March, roughly five years after receiving marketing approval from the Ministry of Food and Drug Safety (MFDS) in February 2021.

This drug can be reimbursed for patients who ▲experienced an average of 3 or more attacks per month over the past 6 months requiring Firazyr (icatibant acetate) administration despite receiving the androgen therapy 'danazol' for at least 6 months ▲required emergency treatment an average of 3 or more times per month in the 6 months before treatment initiation when danazol is banned or cannot be administered due to adverse effects.

​HAE is a rare genetic disorder characterized by recurrent, severe swelling in the face, extremities, abdomen, and particularly the airway, caused by a deficiency·dysfunction of the C1 esterase inhibitor. It is characterized by painful swelling without urticaria or pruritus, and laryngeal edema carries a risk of fatal asphyxiation. Takhzyro is a treatment used for the routine prophylaxis of HAE symptoms. It works by selectively inhibiting plasma kallikrein (pKal), the enzyme responsible for generating bradykinin, thereby preventing angioedema attacks.  

​The efficacy and safety of the drug were confirmed through the global Phase 3 HELP study. The study was conducted in 125 patients with Type I and Type II HAE who experienced an average of 3.7 acute swelling attacks per month.  

​Clinical results demonstrated that the Takhzyro 300 mg every-two-weeks dosing group achieved an 83% reduction in moderate-to-severe acute attacks and an 87% reduction in acute attacks requiring acute treatment compared to placebo.

​Furthermore, in the HELP open-label extension study, which tracked 212 patients for approximately 30 months, a mean 87.4% reduction in acute attacks from baseline was maintained. No new safety signals were identified during long-term administration.

​Professor Kyung-Min Ahn of the Department of Allergy and Clinical Immunology at Ewha Womans University Seoul Hospital stated, "Prophylaxis-centered therapies are the standard of care in major regions such as the United States and Europe. As acute rescue medications and prophylactic therapies are reimbursed, personalized treatments are available. The reimbursement listing of Takhzyro is significant as it aligns domestic clinical practice with global therapeutic strategies."