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Published on 11 June 2012

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Gilenya safety and efficacy ‘consistent for 4.5 years’

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New long-term data for Gilenya® (fingolimod), the only oral therapy approved to treat people with relapsing forms of multiple sclerosis (MS), show a sustained efficacy benefit and a consistent safety profile with up to 4.5 years of continuous treatment.

These results, from an extension of the Phase III head-to-head TRANSFORMS study, also showed improved efficacy for patients switched to Gilenya from Avonex® (interferon-beta-1a IM), a commonly prescribed MS treatment.

“These data further reinforce our confidence in Gilenya’s long-term effectiveness and safety profile. The TRANSFORMS extension study shows that MS patients treated continuously with Gilenya for up to four and a half years demonstrated sustained low levels of clinical and MRI activity,” said Tim Wright, Global Head of Development, Novartis Pharma.

“Furthermore, patients who switched to Gilenya from interferon beta-1a IM showed a reduction in relapses and improvements in MRI measures in the extension compared to the core study.”

In the core TRANSFORMS study, Gilenya demonstrated superior efficacy to interferon-beta-1a IM, reducing the annualised relapse rate (ARR) by 52% at one year (Gilenya 0.5 mg, ARR = 0.16; interferon-beta- 1a IM, ARR = 0.33; p<0.001).

The extension study showed that this low relapse rate was sustained in patients receiving continuous treatment with Gilenya (n=356) for up to 4.5 years (Gilenya 0.5 mg, ARR core study = 0.16; ARR extension study = 0.16).

The data from the extension study also showed that patients treated with Gilenya continuously maintained a low brain atrophy rate throughout the study as measured by assessing brain volume loss, which is valued as a predictor of long-term disability.

For patients who switched to Gilenya for the open-label extension study (n=167), their ARR was 0.33 in the core study when treated with interferon-beta-1a IM and 0.20 in the extension phase when treated with Gilenya (n.s.). Patients in the switch group also displayed a slowing of brain atrophy following the switch to Gilenya.

These extension data from up to 4.5 years also showed long-term treatment with Gilenya was generally well tolerated with a safety profile consistent with pivotal trials.

In line with previous studies, including the core TRANSFORMS study, the most common adverse events were nasopharyngitis, headache, and upper respiratory tract infections.

Switching therapy from IFN beta-1a to Gilenya did not reveal any new or unexpected safety concerns. On treatment initiation, a low incidence of asymptomatic transient bradycardia was observed in patients who switched from interferon-beta-1a IM to Gilenya (IFN-beta-1a 0.5 mg [0.6%]), which resolved without treatment. Overall cardiac events were similar across all patient groups.

In addition, all patients treated with Gilenya in the extension phase, regardless of original treatment in the core study, showed comparable percentage of patients free from MRI disease activity by the end of the study. (Free from Gd enhanced T1 lesions: 77.4% in switch group vs. 74.7% Gilenya 0.5mg; Free from new/newly enlarged T2 lesions: 45.0% in switch group vs. 42.0% Gilenya 0.5mg).

The continuous and switch groups did not significantly differ with respect to disability progression at the end of the study.

“This extension study data provide deeper insight into the efficacy and safety profile of fingolimod, said Dr. Xavier Montalban, Director of the Multiple Sclerosis Center of Catalonia and of the Unit of Clinical Neuroimmunology, Vall d’Hebron University Hospital, Barcelona, Spain.

“The results, which are consistent with the pivotal Phase III studies, confirm that fingolimod is highly effective in treating relapsing forms of MS, and as the first available oral MS treatment, continues to be a valuable treatment option for appropriate patients.”

TRANSFORMS was a large Phase III double-blind, double-dummy, head-to-head study that involved 1292 patients with relapsing-remitting MS that was conducted over one year, comparing the efficacy and safety of Gilenya to interferon-beta-1a IM.

At the end of the 12-month core study, eligible patients could enroll in the extension study, which ran for an additional 3.5 years. Patients on once-daily oral Gilenya remained on drug and those who had been treated with interferon-beta-1a (IM) switched to Gilenya for the duration of the extension study.

These data were presented at the 22nd Annual Meeting of the European Neurological Society (ENS), taking place 9-12 June 2012 in Prague, Czech Republic.

As of February 2012, approximately 36,000 patients have been treated with fingolimod in clinical trials and in the post-marketing setting, some up to seven years, and currently there is approximately 34,000 patient years of exposure.

Novartis



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