GSK's Clonal Myeloid Disorder Treatment Gets Orphan Drug Designation From US, European Regulators
MT Newswires Live
Jun 12
GSK's (GSK) momelotinib has received orphan drug designation from the US Food and Drug Administration and the European Medicines Agency for the treatment of the VEXAS syndrome, the company said on Friday.
VEXAS syndrome is a severe, progressive condition with no approved treatments and a 30% to 40% five-year mortality rate, it added.
The British pharmaceutical giant has planned a phase II/III trial to evaluate the efficacy and safety of momelotinib in VEXAS syndrome that will support upcoming global regulatory submissions.
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