Monday April 04 2011 02:19 PM
Novartis receives European Commission approval for Gilenya®, the first oral multiple sclerosis treatment for use in the EU
Gilenya approved in the EU for people with highly active relapsing-remitting multiple sclerosis (RRMS) despite treatment with beta interferon, or in patients with rapidly evolving severe RRMS
• Gilenya showed superior efficacy to interferon beta-1a IM, a commonly prescribed treatment, reducing relapses by 52% (p<0.001) at one year 1
• Two-year, placebo-controlled study demonstrated that Gilenya significantly reduced the risk of disability progression by 30% after 2 years. 2
March 21, 2011 - The European Commission has granted Novartis approval for Gilenya® (fingolimod) 0.5 mg daily as a disease modifying therapy in patients with highly active relapsing-remitting multiple sclerosis (RRMS) despite treatment with beta interferon , or in patients with rapidly evolving severe RRMS.
“This is an important step in the way we manage this chronic, debilitating disease ” said Professor Orla Hardiman Dept. of Neurology, Beaumont Hospital & Trinity College Dublin. “Gilenya is the first oral therapy for MS, and a welcome addition to our treatment options”
The approval was based on the largest clinical trial program submitted to date for a new MS drug, and included data from clinical studies showing significant efficacy in reducing relapses, the risk of disability progression, and the number of brain lesions detected by magnetic resonance imaging (MRI), a measure of disease activity¹´²
“Today’s announcement marks another major regulatory approval and we are pleased that Gilenya will become available to eligible MS patients” said Dr Greg Hays, Medical Director Novartis Ireland,
“Novartis is dedicated to bringing innovative new treatments to patients where there is significant unmet need. Gilenya has been in clinical development for MS since 2003 and we are grateful for the commitment of those involved, especially the trial participants, who have contributed significantly to the development of this novel medicine. In fact a number of the trial participants were from Ireland where Beaumont Hospital, St Vincent’s Hospital and Cork University Hospital participated in the development programme”
Gilenya is the first in a new class of drugs called sphingosine 1-phosphate receptor (S1PR) modulators. In MS, the immune system damages the covering that protects nerve fibres in the central nervous system (CNS), which includes the brain and spinal cord. The novel mechanism of Gilenya is thought to work by reducing the immune system’s attack on the CNS by retaining certain white blood cells (lymphocytes) in the lymph nodes. This prevents the white blood cells from reaching the CNS, where they could potentially attack the protective covering around the nerve fibers, resulting in less inflammatory damage to the nerve cells. The white blood cell retention is reversible if Gilenya treatment is stopped.
The EU application included data showing Gilenya 0.5mg reduced by 52% (p<0.001) at one year compared with interferon beta-1a (Avonex®), one of the most commonly prescribed treatments for MS.
Data from a two-year placebo-controlled study showed a reduction in the risk of disability progression among Gilenya patients (30% reduction confirmed at three-month follow-up visit p=0.02, compared with placebo) ². In Clinical studies, treatment with Gilenya also resulted in statistically significant reductions in brain lesion activity as measures by MRI.
Gilenya has been studied in more than 4000 MS patients. The most common side effects are headache, liver enzyme elevations, influenza, diarrhoea, back pain, and cough. Other Gilenya-related side effects include transient, generally asymptomatic, heart rate reduction and atrioventricular block upon treatment initiation, mild blood pressure increase, macular edema, and mild bronchoconstriction. ¹´²
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. ¹´²
Avonex®is a registered trademark of Biogen Idec.
1. Cohen et al. Oral Fingolimod vs Intramuscular interferon in Relapsing Multiple Sclerosis. N Engl J Med. Vol 362 NO.5, Feb 4, 2010(printed version)
2. Kappos L, et al.Placebo-Controlled Study of Oral Fingolimod in relapsing Multiple Sclerosis . N Eng J Med. Vol 362 NO 5, Feb 4 2010(printed version)