No Added Benefit Found in New Indication of Multiple Sclerosis Drug

A new therapeutic indication of a drug for patients with highly active relapsing remitting multiple sclerosis (RRMS) who did not respond to full previous treatment with at least 1 disease modifying therapy was found to have no added benefits in a recent trial.

The drug fingolimod (Gilenya) was approved by the FDA in 2011, but in October 2015 the therapeutic indication was modified for patients with highly active RRMS despite treatment with a disease-modifying therapy, such as interferon beta or glatiramer acetate.

The prior diagnostic criteria that called for “highly active” was eliminated and no longer had to have a minimum duration of 1 year.

Prior assessments found that in comparison to the comparator therapy interferon beta, Gilenya showed added benefit for those with rapidly evolving severe RRMS and those who have not received prior full treatment with the interferon beta.

The current assessment conducted did not have these 2 therapeutic indications. Although the modified therapeutic indication did not relate to those with rapidly evolving RRMS, the modification has led to Gilenya no longer being approved for patients who have not received full treatment with the interferon beta.

The results of the assessment by the German Institute for Quality and Efficiency in Health Care found that there was no hint of a greater benefit or harm of Gilenya when compared with the comparator therapy for any of the patient-relevant outcomes investigated in RRMS.