贝罗司他胶囊可预防遗传性血管性水肿!
Hereditary angioedema (HAE) is a disease characterized by recurrent angioedema, clinically manifested as recurrent skin and mucosal edema. HAE is caused by C1 inhibitor deficiency or dysfunction. HAE attacks can be prevented by reducing plasma kallikrein activity.
Berosostat capsules were developed by the pharmaceutical company BioCryst and were approved by the US FDA on December 5, 2020 for the treatment of hereditary angioedema (HAE). The Ministry of Health, Labor and Welfare (MHLW) of Japan has approved the sales and production license of berosostat capsules for the prevention of angioedema (HAE) in adults and children over 12 years old. One capsule of berosostat per day can prevent the onset of HAE by reducing the activity of plasma kallikrein. It is the first and only preventive HAE drug approved in Japan.
In the pivotal Phase 3 clinical trial APeX-2, beroxostat capsules significantly reduced attacks at week 24 and continued through week 48. Patients who completed 48 weeks of treatment (150 mg) experienced a reduction in the number of HAE episodes from an average of 2.9 per month at baseline to 1.0 per month after 48 weeks of treatment. In the long-term open-label trial APeX-S, patients who completed 48 weeks of treatment (150 mg) had an average number of exacerbations per month of 0.8. Berosostat capsules demonstrated good safety and tolerability in both trials.
Abnormal liver function indicators, diarrhea, gastroesophageal reflux, rash, abdominal pain, gastrointestinal reactions, back pain, vomiting, etc. are relatively common side effects of berosostat capsules. This product prevents edema attacks by inhibiting kallikrein to prevent the production of bradykinin. It is a new, oral, once-daily, powerful, selective human plasma kallikrein inhibitor.
Note: The above information comes from the Internet and is compiled and edited by Medical Companion Travel (please correct me if there are any errors or omissions). It is only to provide information on the latest drugs on the market in the world and help Chinese patients understand the latest international new drug trends. It is only for internal discussion among medical staff and does not serve as any basis for medication. For specific medication guidelines, please consult the attending physician.
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