Rare childhood cancer subtype, Ph+ ALL, is found in 3-4% of pediatric cases and 25% of adult cases
The company is already marketing the 4 mg and 10 mg strengths
The product will be produced at the Eugia Pharma Specialities, Unit-I, Medchal, Malkajgiri District, Telangana, India
Olverembatinib is the first and only third-generation BCR-ABL inhibitor approved in China for the treatment of adult patients with tyrosine kinase inhibitors
NDA supported by data from global Phase III FRESCO-2 study in the U.S., Europe, Japan and Australia along with data from Phase III FRESCO study conducted in China
Tofacitinib Tablets, 5 mg and 10 mg had annual sales of US $900 million in the United States (IQVIA MAT December 2022)
The Phase 3 data presented at AAD include a comprehensive review of the THRIVE-AA2 results and further elaborate the topline data reported in August 2022
It will help upgrade the infrastructure and technologies of the country's biopharmaceuticals and in-vitro diagnostic industry
48-week data from MOMENTUM phase III clinical trial show momelotinib maintained total symptom response
Application includes data from key phase III trials, including the pivotal MOMENTUM trial, which met all primary and key secondary efficacy endpoints
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