IQWiG finds added benefit of Novartis’ Gilenya not proven

In an early benefit assessment pursuant to the Act on the Reform of the Market for Medicinal Products (AMNOG), the German Institute for Quality and Efficiency in Health Care (IQWiG) examined whether Swiss pharma giant Novartis’ (NOVN: VX) multiple sclerosis drug Gilenya (fingolimod) offers an added benefit over the appropriate comparator therapy in this patient group.

According to the findings, such an added benefit is not proven: For some of the patients, the drug manufacturer presented no data. For other patients, the available study data either showed no differences between the treatment groups, or the data were not evaluable, said the IQWiG.

Gilenya was approved for an expanded therapeutic indication in May 2014: It is now also available in Germany for adults with highly active relapsing remitting multiple sclerosis (RRMS) who had received other pre-treatment than interferon beta (IFN-β).