The first application of McAb for the treatment of hereditary angioedema in China

Sina medicine was inquired by the official website of the National Drug Examination Center (CDE) and learned that lanadelumab, the first McAb for the treatment of hereditary angioedema (HAE), applied for listing in China on March 29, with the acceptance number of jxss1900011 Photo from: lanalu mAb injection, the official website of CDE, is the only monoclonal antibody drug that can specifically bind and inhibit plasma kallikrein As a preventive treatment drug, it has been approved by the US FDA on August 23, 2018 for use in patients aged 12 and over with hae to prevent the onset of angioedema The half-life of the drug in patients with hae was 14 days, and it was self administered by subcutaneous injection In clinical studies, most patients can complete the injection in one minute or less HAE is a rare and severe autosomal dominant disease The incidence rate is 1/10000 to 1/50000 worldwide Clinically, patients with hae may have a recurrent acute attack of soft tissue edema involving multiple anatomical sites (including gastrointestinal tract, facial tissue, vocal cord and larynx, oropharynx, urogenital region and / or both arms and legs) A throat attack can be life-threatening due to the risk of suffocation At present, there is no effective treatment In 2018, takhzyro was approved in the United States based on data from four clinical studies, including a key phase III clinical study help, which is the largest preventive study in the field of hae so far, involving 125 patients aged 12 years and over with type I / II hae The results showed that compared with placebo, once every two weeks and 300mg dose of lanalu mAb significantly reduced the number of monthly hae episodes by 87%; once every four weeks and 300mg dose of lanalu mAb significantly reduced the number of monthly hae episodes by 73% Therefore, the recommended starting dose of takhzyro in the United States is 300mg every two weeks The 300mg dose interval every 4 weeks is also effective If the patient's condition is well controlled (for example, no attack) for more than 6 months, the dose interval can be considered It is understood that the lanalurenmab injection applied for listing is from shire, a manufacturer of rare disease drugs under Takeda pharmaceutical, and dyax Corp was acquired by shire in 2016 Ecallantide, the main asset of dyax company, is also a hae treatment drug, which was first listed in the United States in 2009 It has been included in the first batch of clinically urgent overseas new drugs in 2018, but has not yet applied for listing in China Picture from: list of the first batch of overseas new drugs urgently needed in clinic