GSK PLC (LSE:GSK, NYSE:GSK) has received a positive recommendation from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) for its drug, momelotinib, a treatment for the rare blood cancer myelofibrosis.
This thumbs-up is a crucial step towards the drug's potential approval in the European Union (EU).
Momelotinib is poised to be the first and only treatment in the EU specifically designed for myelofibrosis patients suffering from moderate to severe anaemia.
The disease is a type of bone marrow cancer that disrupts the body's normal production of blood cells, often leading to an enlarged spleen and severe anaemia.
The CHMP's positive opinion is based on momelotinib's effectiveness in treating symptoms related to myelofibrosis, including disease-related splenomegaly (enlarged spleen).
The drug is suitable for patients who are either newly diagnosed or have previously been treated with ruxolitinib, another medication used for myelofibrosis.
The European Commission will make the final decision on the marketing authorisation for momelotinib, expected by early 2024.
If approved, this will mark a significant advancement in the treatment options available for myelofibrosis patients in the EU, particularly those grappling with the challenging complication of anaemia.
In early trade, GSK shares were changing hands for 1,406p, up 7.6p.