A decision on EU marketing authorisation for oral therapy is expected by early 2024.
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approving an oral therapy to treat myelofibrosis patients with moderate to severe anaemia.
Myelofibrosis is a rare blood cancer that affects the body’s normal production of blood cells, and the affected patients are likely to develop anaemia over the course of the disease.
British drugmaker GSK, the manufacturer of the oral therapy known as momelotinib, said that it can be used to treat "both newly diagnosed and previously treated myelofibrosis patients."
The medicine helps address disease-related splenomegaly (enlarged spleen) or symptoms in adult patients who are Janus kinase (JAK) inhibitor naïve or have been treated with ruxolitinib, as stated by the company.
Nina Mojas, Senior Vice President of Oncology Global Product Strategy at GSK, said that receiving the positive CHMP opinion “is a significant step in bringing momelotinib to patients in the EU with this difficult-to-treat blood cancer.”
According to the company, the CHMP opinion is one of the final steps prior to a marketing authorisation decision by the European Commission.
If approved, momelotinib will become “the first and only treatment in the European Union (EU) specifically indicated for myelofibrosis patients with moderate to severe anaemia.”
A decision on EU marketing authorisation for momelotinib is expected by early 2024.
The British drugmaker noted that the positive CHMP opinion is supported by data from the pivotal MOMENTUM study and the SIMPLIFY-1 phase III trial.
“MOMENTUM was designed to evaluate the safety and efficacy of momelotinib versus danazol for the treatment and reduction of key manifestations of myelofibrosis in an anaemic, symptomatic, JAK inhibitor-experienced population.
“SIMPLIFY-1 was designed to evaluate the efficacy and safety of momelotinib versus ruxolitinib in myelofibrosis patients who had not received a prior JAK-inhibitor therapy,” it explained.
The most common adverse reactions reported during these clinical trials were diarrhoea, thrombocytopenia, nausea, headache, dizziness, fatigue, asthenia, abdominal pain and cough.
The oral drug, if approved in the EU, will be available under the proposed trade name Omjjara, the company said.
In September 2023, the US Food and Drug Administration (FDA) approved momelotinib for the treatment of intermediate or high-risk myelofibrosis in adults with anaemia under the brand name Ojjaara.
However, momelotinib has not been approved in any other market as yet.
