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Based on the results of the Phase 3 MOMENTUM trial, the FDA has accepted a new drug application
According to a press release from drug developer GSK.
Acceptance is based on the results of the Phase 3 MOMENTUM trial (NCT04173494), which evaluated the drug compared to danazole in a group of symptomatic patients previously treated with JAK inhibitors
The results of this trial were presented
At 24 weeks, 72.
In terms of spleen response rate at 24 weeks, patients in the momelotinib group were reduced by 25% in 40.
In the domelotinib and danazol groups, grade 3 or higher AE was observed in 53.
Resources:
- US FDA accepts new drug application for GSK’s momelotinib for the treatment of myelofibrosis.
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