FDA approves an application for license for complementary biologics from Romiplostim

recently, biotech giant Amgen announced that the u.SFood andDrug(http://Administration (
FDAhttp://) has approved a license application for supplementary biologics (sBLA)The sBLA was based on an open single arm Phase IItrial(http://, which included 75 adult patients who were diagnosed with ITP for up to 6 months and had inadequate responses to first-line therapies, including corticosteroids (9 squares/L of platelet counts of 30 x 10)the median time between the time of diagnosis of ITP and the beginning of the study was 2.2 monthsDuring the 12-month treatment period in the study, patients received an Nplate subcutaneous injection once a week and underwent individual dose adjustments to maintain platelet count (50-200 x 10 9 squares/L)In terms of primary endpoints, the median monthof of platelet response (9 squares/L) during the 12-month treatment period (95% CI:10,11) was 11 months, and the median time of the first platelet response was 2.1 weeks (95% CI: 1.1, 3.0)In addition, 93% (70) patients had one or more platelet responses during 12 months of treatmentat the second endpoint, 32% (24) of patients achieved at least 6 months of remission, defined as 9 squares/L of maintaining platelet counts of 50 x 10 without Nplate and any ITP drug (accompanied or rescued) security in this trial, Nplate's security was similar in patients, regardless of the duration of the ITP Adverse reactions (incidence at least 5% and 5% higher than placebo or standard care) in patients with ITP duration of 12 months include: bronchitis, sinusitis, vomiting, joint pain, myalgia, headache, dizziness, diarrhea, upper respiratory tract infections, cough, nausea and sore throat in adult patients with 12-year-old ITP, the incidence of adverse reactions to thromtosis was 2%