Biopharmaceutical company GSK plc (LSE: GSK) (NYSE: GSK) announced on Monday that it has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommending the approval of momelotinib for the treatment of disease-related splenomegaly or symptoms in adult patients with moderate to severe anaemia and specific types of myelofibrosis.

If approved, momelotinib will be the first and only treatment in the EU specifically indicated for these patients. A decision on EU marketing authorisation is expected by early 2024.

Momelotinib is designed to address significant medical needs and will provide a unique solution for myelofibrosis patients with moderate to severe anaemia. The CHMP opinion follows positive data from the MOMENTUM study and SIMPLIFY-1 phase III trial, supporting its efficacy in an anaemic population. GSK aims to offer a differentiated treatment option with momelotinib, leveraging its distinct mechanism of action.

The positive CHMP opinion sets the stage for potential EU approval, allowing momelotinib to be available under the proposed trade name Omjjara. GSK has previously received FDA approval for momelotinib in the United States.

Myelofibrosis is a rare blood cancer impacting blood cell production and momelotinib's unique mechanism targets key signaling pathways, providing a potential breakthrough for patients.