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Orladeyo (Berotralstat)
申请企业
BIOCRYST PHARMACEUTICALS INC
药品名称
Orladeyo (Berotralstat)
承诺描述
Submit the final clinical study report (CSR) from Parts 2 and 3 of theongoing Study BCX7353-302 with berotralstat in patients 12 years andolder with Type I and Type II hereditary angioedema (HAE) to provide longterm efficacy and safety assessments, including clinical laboratory testssuch as LFT elevations, HAE attack data, occurrence of adverse events,hospitalizations and deaths.