EMA accepts filing for momelotinib as treatment of myelofibrosis

The marketing authorization application (MAA) for momelotinib, an investigational oral treatment for myelofibrosis, submitted by UK pharma major GSK (LSE: GSK), has been accepted for review by the European Medicines Agency (EMA).

The application includes data from the MOMENTUM Phase III clinical trial, which met all primary and key secondary efficacy endpoints.

Momelotinib was most recently developed by Sierra Oncology, which GSK acquired for around $1.9 billion in July 2022, building on UK firm’s expertise in hematology and portfolio of specialty medicines and vaccines.