Novartis has reported the latest clinical data for its multiple sclerosis (MS) drug Gilenya , confirming the drug’s effectiveness and safty profile.
The Swiss pharma says the 1,083-patients Phase III 2309 study, evaluating Gilenya in patients with relapsing-remitting multiple sclerosis, met its main goal, showing that patients treated with Gilenya less likely to have a relapse in symptoms compared those who took a placebo. Patients with relapsing-remitting MS treated with Gilenya had a 48% reduction in annualised relapse rates at 24 months compared to placebo. The secondary endpoint was also achieved by demonstration statistical significant reduction of brain volume loss.
These new results also were consistent with data from two previous clinical trials, which showed reductions in relapse rates for patients on Gilenya compared to both placebo and Merck Serono’s Rebif (interferon beta-1a).
Gilenya, also known the generic name fingolimod, was licensed from Mitsubishi Tanabe Pharma by Novartis. The drug won FDA approval on September 22, 2010 to reduce relapses and delay disability progression in patients with relapsing forms of multiple sclerosis. The European Medicines Agency approved Gilenya on March 17, 2011.
“Study 2309 confirms the efficacy of Gilenya across several key measures, including reductions in annualised relapse rate and reductions in brain volume loss,” said David Epstein, head of Novartis’ Pharmaceuticals Division said, “With more than 20,000 patient years of fingolimod exposure to date, Gilenya continues to demonstrate its value to patients and the MS community. We are looking forward to presenting the full data to the clinical community at a scientific congress next year.”
Novartis said earlier this week it was investigating whether Gilenya was linked to the death of a patient who had just started the treatment with the drug. The company noted that “a role for Gilenya can neither be confirmed nor excluded at this time.”
The new phase III trial was primarily conducted to provide specific safety data for the NDA of Gilenya submitted to US FDA in 2009. The data from Study 2309 indicated Gilenya’s safety and tolerability was consistent with what showed in earlier trials. Gilenya treated patients in the trial had experienced adverse events of elevations of liver transaminase, hypertension and low levels of lymphocytes. However, Incidents of more serious events were rare and no deaths were recorded during the trial.