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    Home > Medical News > Medical World News > Biotralstat, a plasma kallikrein inhibitor of biocryst, is under review in the United States

    Biotralstat, a plasma kallikrein inhibitor of biocryst, is under review in the United States

    • Last Update: 2020-02-19
    • Source: Internet
    • Author: User
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    Biocryst pharmaceutical company is committed to finding new, oral, small molecule drugs for the treatment of rare diseases where enzymes play a key role in the biological pathway of diseases and there are significant unmet medical needs Recently, the company announced that the U.S Food and Drug Administration (FDA) has accepted the new drug application (NDA) of bertralstat (bcx7353), a drug taken orally once a day to prevent the attack of hereditary angioedema (HAE) FDA has designated the target date of PDUFA as December 3, 2020 In the NDA acceptance letter, FDA said it does not intend to hold a meeting of the Advisory Committee to discuss NDA at present The NDA submitted this time is an oral capsule of bertralstat to prevent the attack of HAE Another oral liquid preparation of bertralstat, currently in phase II clinical, is developed for the treatment of acute hae attack Bertralstat is a new, oral, once a day, powerful, selective human plasma kallikrein inhibitor, which is currently in the late clinical development, and is used to prevent and treat the onset of angioedema in patients with hereditary angioedema (HAE) In phase III apex-2 and phase II apex-1 clinical trials, bertralstat showed good safety and tolerance In the phase III apxe-2 clinical trial, compared with placebo, bertralstat (150mg) significantly reduced the hae attack rate by 44% (P < 0.001), and in 50% of patients, the hae attack rate decreased by ≥ 70% At present, biocryst company is carrying out apex-s, which is a long-term safety clinical trial In addition, biocryst also completed the zenith-1 clinical trial, which is a phase II clinical trial of concept validation, and evaluated the treatment of acute angioedema attack with peroralstat oral liquid preparation Mechanism of action of bertralstat In addition to the U.S FDA, biocryst plans to submit the listing application documents of biotralstat oral capsule for prevention of hae attack to Japanese drugs and medical devices (PMDA) and European Drug Administration (EMA) in the first quarter of 2020 Jon Stonehouse, CEO of biocryst, said: "the hae patient population and its doctors have been waiting for once a day oral therapy to prevent the onset of the disease FDA accepts the NDA of our bertralstat and designates December as the target date of PDUFA, which means the waiting of patients and doctors is coming to an end We will build an experienced business team and carry out our business plan, and prepare to quickly launch our products to the U.S market after the approval of bertralstat "
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