美国批准贝罗司他胶囊预防遗传性血管性水肿(HAE)发作

BioCryst announced on December 3, 2020 that the once-daily oral (berotralstat) it developed was approved by the US FDA for the prevention of hereditary angioedema (HAE) attacks in children and adults aged 12 years and older.

Beroxostat capsules (150 mg once daily) significantly reduced the number of HAE episodes over 24 weeks in patients in the pivotal Phase 3 APeX-2 trial, and this continued through week 48. After completing the 48-week trial, essentially all patients experienced a significant reduction in the frequency of HAE attacks, from an average of 2.9 attacks/month at baseline to an average of 1 attack/month. It can be seen from this that the therapeutic effect of Berostat capsule is very excellent.

Berotralstat was safe and well-tolerated in both studies, with the most common adverse effects being gastrointestinal compared with placebo. Usually the incidence is higher in the early stages of treatment, then gradually decreases, and patients usually resolve on their own. Generally, it is a short-lived, itchy rash, abdominal pain, diarrhea, back pain, vomiting, abnormal liver function indicators, gastroesophageal reflux disease, etc.

During the period of using berotralstat capsules, it is recommended that patients strictly follow the doctor's instructions to take the medication to maximize the effect of berotralstat capsules. They must not change the medication time and dosage on their own. You must know that even if you increase the dosage of the drug, there is no way to improve the actual therapeutic effect of the drug. On the contrary, it may cause more adverse reactions, so do not use the drug blindly.

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.