Takeda Dazeyou was approved to enter China to fill the domestic HAE long-term non-targeted treatment gap

Takeda China announced that its innovative drug Dazeyou ® (Lanaliyu single anti-injection) has been approved by the State Drug Administration and is suitable for the prevention of hereditary angioedema (HAE) in patients 12 years of age and older.
Dazeyou® (Lanaliyu monoantigenic injection) is currently the world's only monoclonal antibody (mAb) drug for hereditary angioedema, can reduce the number of recurrent episodes of edema in patients, prevent asphyxiation caused by fatal throat edema, improve the quality of life of patients and their families, fill the gap in China HAE long-term non-targeted treatment.
As the world's first monoclonal antibody for HAE long-term preventive treatment, Dazeyou ® (Lanaliyu monoantigen injection) was first licensed to market in the United States in 2018, according to the National Drug Administration/National Health Board's Bulletin on The Review and Approval of Optimised Drug Registration (No. 23 of 2018), for the prevention and treatment of overseas listings Serious life-threatening and no effective treatment of diseases and rare diseases of drugs, imported drug registration applicants after research that there is no ethloymic differences, can submit overseas obtained clinical trial data directly declared drug registration applications, so Dazeyou ® (Ranaliu single anti-injection) in less than two years was successfully approved into China, making the international innovative drug quickly benefit China HAE patients.
Dazeyou® (Lanaliyu monoantigen injection) has been recommended by haE guidelines in the United States and Canada as a first-line therapy, can target inhibition of the patient's body's active plasma peptide release enzyme, to prevent the onset of disease.
the main endpoints of a Phase III clinical study, HELP (Long-Term Preventive Treatment of Genetic Angioedema ™), showed that 300 mg of treatment every 2 weeks reduced the number of HAE episodes by an average of 87% per month compared to the placebo group.
In addition, the results of the exploratory study showed that during the 16-week steady-state phase of the study (days 70 to 182), 77 percent of patients in the treatment group who received a 300 mg dose once every 2 weeks achieved zero seizures and 3 percent in the placebo group;
hereditary angioedema is a rare genetic disease that can threaten a patient's life, with a reported prevalence rate of about 1 in 50,000 people.
Because the patient's body lack of C1sterase inhibitors (C1INH) or its function defects, so that its limbs, face, genitals, respiratory tract and gastrointestinal mucosa and other parts of the body without warning acute edema, accompanied by severe abdominal colic and nausea, vomiting, resulting in patients can not work and study, so that many patients have depression and anxiety.
, the most deadly of these is upper respiratory mucosal edema, which can rapidly progress leading to breathing difficulties or asphyxiation, life-threatening.
statistics, 58.9% of HAE patients in China have had throat edema, the fatality rate as high as 11% to 40%, is one of the main causes of death of HAE patients.
May 2018, the First Rare Diseases Directory, published by the National Health Board in five departments, listed hereditary angioedema as one of the first 121 rare diseases.
, the public and doctors know little about hereditary angioedema, and the diagnosis rate is expected to be less than 5%.
and diagnosed patients can only long-term use of weak androgens or antifibrin dissolvers, limited effects of control of seizures and adverse reactions, such as liver damage, osteoporosis, masculinity, affecting growth and development, thromboembolism, resulting in patients because of fear of side effects of drugs refused to take drugs, long-term in the difficult situation of no medicine.
approval of the ® "Dazeyou" (Lanaliyu mono-injection) fully reflects Takeda's consistent commitment to supporting the HAE community worldwide.
the future, we will further improve the access ® of the Dazeyu (Lanaliyu monoantigen injection) in China.
"Thanks to a series of recent policy reforms by the government that have encouraged innovative drugs, more and more patients are benefiting early from important therapies such as Dazeyou® (Ranaliyu monoantigen injection)," said Mr. Shan Guohong, president of takeda China.
We have always maintained a 'patient-centric' core philosophy and plan to introduce more than 15 highly innovative drugs within five years to help Chinese patients achieve a globally synchronized and innovative experience.
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