The immunosuppressant fingolimod hydrochloride (trade name Gilenya) was approved in May 2014 for a new indication; adults with highly active and relapsing-remitting multiple sclerosis (RRMS). The Institute for Quality and Efficiency in Health Care (IQWiG) has conducted an early benefit assessment pursuant to the Pharmaceutical Market Restructuring Act (AMNOG) to determine whether it provides an additional clinical benefit in this patient group.

Such an additional benefit is therefore not used: for some patients, the manufacturer has not provided data for another part, the available study data either no differences between the treatment groups or the data is not usable.

For more details, go to: https://www.iqwig.de/de/presse/pressemitteilungen/pressemitteilungen/fingolimod-in-neuem-anwendungsgebiet-zusatznutzen-nicht-belegt.6340.html?&et_cid=4&et_lid=%25208 [German]