GSK plc (GSK,GSK.L) announced that momelotinib has received Orphan Drug Designation from the FDA and European Medicines Agency for the treatment of VEXAS syndrome. The company said the planned phase II/III ATLAS trial will evaluate momelotinib's efficacy and safety in VEXAS syndrome and will support planned global regulatory submissions.
Momelotinib is currently approved in the US for the treatment of intermediate- or high-risk myelofibrosis in adults with anaemia. It is also approved in the EU and UK for the treatment of myelofibrosis with disease-related splenomegaly or symptoms in adults with moderate to severe anaemia.
At last close, GSK shares were trading at 1,962.50 pence, up 2.13%.
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