European Regulatory Agency Finds Gilenya Not of Added Benefit to Certain RRMS Patients

A new assessment by a European regulatory agency failed to find fingolimod of added benefit to comparator therapies for people with highly active relapsing-remitting multiple sclerosis (RRMS) who have failed to respond to treatment with at least one other disease-modifying drug.

Fingolimod (Gilenya), developed as a therapy for multiple sclerosis, has undergone three early benefit assessments since its approval in 2011. All were based largely on data from the TRANSFORMS Phase 3 clinical trial, showing the drug offered long-term benefits, including a reduction in the annualized relapse rate and in disease activity. Results from these assessments indicated that fingolimod provided an added benefit when compared with the appropriate comparator therapy, interferon beta, for patients with rapidly progressing severe RRMS, and for patients who have not been previously treated with interferon beta.

This latest evaluation was necessitated by a 2015 change in the drug’s therapeutic indication by supervisory authorities, and pertained only to treatment for highly active RRMS patients who were unresponsive to a full round of treatments with a therapy such as interferon beta or glatiramer acetate, according to a press release. At the time, it was decided that fingolimod was no longer approved for patients who had not yet received full treatment with interferon beta. Previous diagnostic criteria for “highly active” were eliminated, and prior therapy no longer had to have a minimum duration of one year.

The Federal Joint Committee (G-BA) assigned the German Institute for Quality and Efficiency in Health Care (IQWiG) to assess the further benefit of fingolimod in the context of its changed indication, in accordance with the Act on the Reform of the Market for Medicinal Products (AMNOG). The G-BA early benefit assessment concluded that fingolimod does not provide an added benefit for this patient population, the release stated.

The finding of a lack of confirmation of enhanced benefit in patients with highly active RRMS patients, despite full prior treatment with at least one disease-modifying drug, concurs with the 2014 assessment on this therapeutic indication.

After publication of this dossier assessment, the G-BA will conduct a commenting period before making a final decision on the extent of the added benefit of fingolimod treatment in this RRMS patient group.

Most people with the disease have RRMS, whose symptoms begin to manifest when they are in their 20s or 30s. Patients with RRMS may have attacks when symptoms flare up, called relapses. An attack is followed by a time of recovery when patients have few or no symptoms, called remission; this period can last weeks, months, or longer. After 10 to 20 years, RRMS usually changes to a different type of MS called secondary progressive MS, in which patients won’t have relapses as often, but the disease will gradually worsen.