Novartis confirms growing Gilenya® clinical experience

“As the first once-daily oral MS therapy, we are pleased Gilenya has played such an important role in addressing unmet medical need in the MS community in the two years following initial approvals,” said David Epstein, Head of the Pharmaceuticals Division of Novartis Pharma AG. “Our growing experience reinforces Gilenya’s high efficacy and very good tolerability profile and Novartis remains committed to ensuring eligible patients have access to Gilenya.”

Gilenya is the only approved treatment shown to consistently decrease brain volume loss.[2,3] Brain volume loss is the best magnetic resonance imaging (MRI) correlate of long-term disability.  New data presented at the recent 65th Annual Meeting American Academy of Neurology (AAN), showed that Gilenya reduced the rate of brain volume loss by about one-third compared to interferon beta-1a IM or placebo in studies with over 3,600 patients with relapsing MS.[4] Patients from a Phase II study who remained on treatment for up to seven years experienced consistently low rates of brain volume loss.[5]

Data has also shown significant efficacy with Gilenya in reducing relapses and slowing of six-month disability progression sustained at four years.[6] Nearly half of Gilenya patients were disease-free after one year of treatment[7,8] and in the pivotal FREEDOMS study, eight out of ten patients on the approved dose remained on treatment at two years.[2]

In clinical trials Gilenya exhibited a well-characterised safety profile and very good tolerability profile.[2,3]

Gilenya was approved based on the largest phase III clinical trial program in MS at the time of submission, which included a head-to-head study versus Avonex® (interferon beta-1a IM), a commonly prescribed treatment. Gilenya is now approved in 70 countries, and there is approximately 73,000 patient years of exposure.[1]

Up to 2.5 million people worldwide are affected with MS,[9] a neurodegenerative condition that often begins in early adulthood.[10] Around 70% of newly diagnosed patients with MS are in the prime of their lives – between 20 and 40 years of age – so most people are employed at the time of diagnosis. This can have a significant impact on careers, quality of life and families.[11,12]

Gilenya is the first oral therapy approved to treat relapsing forms of MS and the first in a new class of compounds called sphingosine 1-phosphate receptor (S1PR) modulators. Gilenya is thought to act on inflammatory processes implicated in the MS disease process.[13,14]

Gilenya has demonstrated superior efficacy compared to Avonex® (interferon beta-1a IM), a commonly prescribed treatment, showing a 52% relative reduction in annualised relapse rate (primary endpoint) at one year in a pivotal head-to-head trial in patients with relapsing-remitting multiple sclerosis.[3] In a post hoc sub-group analysis, Gilenya showed a 61% relative reduction in annualised relapse rate compared to interferon-beta-1a IM at one year in subgroups of patients with highly active relapsing-remitting MS not responding to interferon treatment.[15]

In clinical trials Gilenya exhibited a well-characterised safety profile and very good tolerability profile.[2,3] The most common side effects were headache, liver enzyme elevations, influenza, diarrhoea, back pain, and cough. Other Gilenya-related side effects included transient, generally asymptomatic, heart rate reduction and atrioventricular block upon treatment initiation, mild blood pressure increase, macular oedema, and mild bronchoconstriction.[2,3]

The rates of infections overall, including serious infections, were comparable among treatment groups, although a slight increase in lower respiratory tract infections (primarily bronchitis) was seen in patients treated with Gilenya. The number of malignancies reported across the clinical trial program was small, with comparable rates between the Gilenya and control groups.[2,3]