Novartis’ multiple sclerosis pill Gilenya (fingolimod) has failed to offer a significant benefit to patients with the rarer primary progressive form of the disease (PPMS).
The Swiss drug giant has released Phase III data showing that its drug failed to show a significant difference to placebo on a combination of disability measures.
On the plus side, safety results from the INFORMS trial were consistent with Gilenya’s established tolerability profile.
Around 10% of MS patients (2.3 million) suffer from primary progressive form, which is very distinct from the more common RRMS, but as yet there are no approved treatments able to change the course of the disease.
News of Gilenya’s failure in this setting, particularly given its success as the first disease-modifying treatment for RRMS, will no doubt be very disappointing for patients.
“Finding effective treatments remains a challenge. We will actively work with the MS community to review and analyze the INFORMS results to help increase the understanding of this devastating disease," noted Vasant Narasimhan, Global Head of Development at Novartis.