A study by researchers at the Queen Mary University of London has found that a drug blocked by European regulators can improve the quality of life for people with multiple sclerosis.
The team of researchers reached this conclusion after uncovering previously unpublished clinical trial data from the European Medicines Agency. The European Commission is currently considering whether it will reverse its decision to deny a license for the oral formulation of the drug, cladribine.
Injectable cladribine is traditionally licensed as a therapy for certain cancers. But a 1,326-patient trial that enrolled people with MS found that it was highly effective in controlling relapses, lesions in the brain and the progression of disability.
The EMA rejected license applications from cladribine’s unnamed drug manufacturer, which stopped commercial development of the drug back in 2011. The researchers said the license was denied for a number of reasons, including an increase in cancer risk. The team pointed out that later research showed that the increase in cancer risk was an anomaly.
“Cladribine seemed to have such excellent potential as a treatment for MS that we thought it was tragic the development programme was shelved, and significant parts of the clinical trial data remained unpublished,” lead researcher Dr. Klaus Schmierer said in prepared remarks.
“In addition to the drug being highly effective, well tolerated, and safe as far as short term studies can show, we now know it also improves patients’ quality of life. The new results seemed so clear, we felt it was extremely important to publish and share these data.”
The researchers’ analysis evaluated quality-of-life data collected from a self-completed questionnaire. The questionnaire included topics like the patient’s mobility, self-care, pain, anxiety and activity.
After almost two years, the patients taking cladribine reported significantly improved quality-of-life scores compared to patients taking a placebo.
The drug also doesn’t seem to be linked with any severe adverse effects, the researchers reported.
In June, after researchers demonstrated that cladribine does not hieghten a patient’s risk of cancer, the EMA adopted a positive opinion for oral caldribine as a treatment for highly active relapsing MS. The European Commission, which is currently considering the EMA’s recommendation, is slated to announce its decision soon.