The NDA submission was based on the multiple P-II & III studies including (MOMENTUM) study to evaluate momelotinib in patients with myelofibrosis who were symptomatic & anemic, and prior treated with the US FDA-approved JAK inhibitor. The product is expected to be available in 2023
The P-III (MOMENTUM) study’s 1EPs is a TSS reduction of >50% over the 28 days vs baseline TSS, while the 2EPs included a TI rate of>12wks. before the end of 24wk. with Hgb levels of 8 g/dL, SRR based on splenic volume reduction of >35% @24wk.
Momelotinib is an ACVR1 / ALK2, JAK1, JAK2 inhibitor that is being studied for myelofibrosis in symptomatic, anaemic patients who have previously been treated with an approved JAK inhibitor
The P-III (MOMENTUM) study’s 1EPs is a TSS reduction of >50% over the 28 days vs baseline TSS, while the 2EPs included a TI rate of>12wks. before the end of 24wk. with Hgb levels of 8 g/dL, SRR based on splenic volume reduction of >35% @24wk.
Momelotinib is an ACVR1 / ALK2, JAK1, JAK2 inhibitor that is being studied for myelofibrosis in symptomatic, anaemic patients who have previously been treated with an approved JAK inhibitor
Ref: Businesswire | Image: Sierra Oncology
