Multiple Sclerosis Drug Gilenya (Fingolimod) Approved By FDA

Gilenya (fingolimod) 0.5 mg daily for the treatment of relapsing forms of multiple sclerosis has been approved by the Food and Drug Administration. Swiss pharmaceutical company, Novartis, says that Gilenya is the first oral medication indicated for relapsing forms of multiple sclerosis (MS) in the United States – it reduces the frequency of MS flare-up, as well as helping slow down the build-up of some of the physical problems associated with MS.

Clinical trials involving 2,600 patients demonstrated a well-studied safety and tolerability profile, Norvartis informs. Some of the trial participants were in their seventh year of Gilenya treatment.

Nicholas LaRocca, VP, Healthcare Delivery and Policy Research, the National Multiple Sclerosis Society, said:

Today is a significant and encouraging day for people with relapsing forms of MS in the US. A new treatment option that offers significant efficacy in the convenience of a capsule is a welcome alternative to frequent injections for individuals living with this chronic disease.

Fred Lublin, MD, Saunders Family Professor of Neurology, The Corinne Goldsmith Dickinson Center for Multiple Sclerosis, Mount Sinai School of Medicine, said:

Through a novel mechanism of action, Gilenya can significantly improve clinical outcomes among patients with relapsing forms of MS. Gilenya provides significant efficacy and manageable safety when used in accordance with approved labeling, making it a valuable advancement for relapsing MS patients and the physicians who treat them.

Novartis writes that the Gilenya clinical trial that was submitted to the FDA was the largest ever for a new MS medication; it included combined findings from trials that demonstrated significant efficacy in reducing MS relapses, disability progression risk, and the total number of brain lesions detected by MRI (magnetic resonance imaging).

Trevor Mundel, MD, Global Head of Development at Novartis Pharma AG., said:

We are proud to have worked successfully with the MS community toward a shared goal of bringing a novel efficacious treatment to people with relapsing forms of MS. We are actively pursuing regulatory approval in Europe and the rest of the world.

Gilenya is a sphingosine 1-phosphate receptor (S1PR) modulator, the first in this new class of medication. The immune system of MS patients damages the covering that protects CNS (central nervous system) nerve fibers – the nerves in the spinal cord and brain. Scientists believe that Gilenya works by retaining specific lymphocytes (white blood cells) in the lymph nodes, thus reducing the immune system’s attack on the central nervous system. If the white blood cells can be prevented from reaching the CNS there is less inflammatory damage to the nerve cells.

When the patient stops taking Gilenya, the white blood cell retention is reversed, Novartis explained.

Scientists stress that Gilenya does not cure multiple sclerosis; it can, however, slow down the accumulation of physical problems that MS may cause.

Clinical trials showed that Gilenya 0.5 mg reduced the number of relapses by 52% at one year compared with Avonex (interferon beta-1a IM).

Gilenya also reduced disease activity as measured by the number of new and newly enlarged T2 lesions on MRI scans compared to interferon beta-1a IM (1.6 vs 2.6, respectively, P=0.002) at one year.

In a two-year study, Gilenya demonstrated a reduction relapse rate of 54% compared to a placebo, as well as a 30% reduction of disability progression.

Researchers in both studies also reported statistically significant reductions in brain lesion activity.

In December 2009, Gilenya was submitted to the EMA (European Medicines Agency) as well as to the FDA. The EMA regulatory review, as well as others in various parts of the world are still ongoing.