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Novartis releases trial results backing Gilenya safety profile

Data comes just days after a patient died after starting on the MS treatment

Novartis says new late-stage trial results for Gilenya (fingolimod) confirm the safety record of its oral multiple sclerosis drug.

Earlier this week the pharma company said it was investigating whether the drug was linked to the death of a patient who died shortly after starting on Gilenya.

Novartis previously said the role of Gilenya in the patient's death, which occurred within 24 hours of first taking the drug on November 23, could neither be excluded or confirmed.

The company said the new phase III trial results for Gilenya indicated its safety and tolerability was consistent with earlier studies.

Adverse events documented among Gilenya users in the trial included elevations of liver transaminase, hypertension and low levels of lymphocytes. Incidents of more serious events, such as systematic low heart rate and associated atrioventricular blockages, were rare and no deaths were recorded.

The trial, called Study 2309, was mainly performed to provide further safety data required by Gilenya's US approval last year.

The two-year placebo-controlled, parallel-group, multi-center phase III clinical trial  involved 1,083 patients across 126 sites in eight countries with most of patients enrolled in the US.

Novartis said study 2309 suggested that use of Gilenya, an oral treatment for relapsing-remitting multiple sclerosis (RRMS), showed a significant reduction in annualised relapse rate, meeting its primary endpoint.

RRMS patients treated with the drug had a 48 per cent reduction in annualised relapse rates (ARR) at 24 months compared to placebo. These results also backed up two previous trials, which showed reductions in relapse rates for patients on Gilenya compared to both placebo and Merck Serono's Rebif (interferon beta-1a).

Brain volume loss, a predictor of long-term disability, was also shown to achieve significant reduction in Gilenya patients compared to placebo.

David Epstein, head of Novartis' Pharmaceuticals Division said: "Study 2309 confirms the efficacy of Gilenya across several key measures, including reductions in annualised relapse rate and reductions in brain volume loss.

"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."

Gilenya is the first drug of its class approved in the EU and the US, but has yet to be accepted by the National Institute for Health and Clinical Excellence (NICE) for use on the NHS in England and Wales.

NICE's second draft guidance on Gilenya said that, even with a patient access scheme proposed by Novartis, the benefits of the drug were not worth its expense.

16th December 2011

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