Oral pill FTY720 to treat multiple sclerosis approved

A new pill FTY720 has been approved as oral treatment for multiple sclerosis.

FTY720 which contains fingolimod as active drug has been found reducing relapses and delaying progression of disability associated with multiple sclerosis.

FTY720 would potentially be the first oral therapy for treating relapsing multiple sclerosis.

FTY720 would be the first in a new class of therapies developed for relapsing multiple sclerosis called sphingosine1-phosphate receptor (S1PR) modulators, which work by retaining certain immune cells (lymphocytes) in the lymph nodes, preventing them from reaching the central nervous system and causing damage.

This lymphocyte retention is reversible, allowing circulating lymphocytes to regain normal levels if treatment is stopped.

Novartis has submitted the largest clinical trial program ever submitted to US FDA as part of an multiple sclerosis new drug application.

This study data provided evidence of superior efficacy of FTY720 over one of the most commonly prescribed treatments, interferon beta-1a IM Avonex, in reducing relapses and brain lesions (a measure of disease activity).

Two other studies showed FTY720 significantly delayed disability progression.

US FDA granted FTY720 priority review status in February 2010, reducing the standard 10-month review to six months.

In May, the FDA extended the priority review period by three months to September 2010.

The safety profile of FTY720 has been well studied and includes more than 4,500 patient years of experience, with some patients in their seventh year of treatment.

Multiple sclerosis is thought to be an autoimmune disease of the central nervous system that is chronic, progressive and often disabling.

It affects over 400,000 Americans and up to 2.5 million people worldwide. The most common form of the disease, relapsing multiple sclerosis, is characterized by exacerbations or “flare-ups” interspersed with periods of disease remission.

Typically, multiple sclerosis strikes in early adulthood between the ages of 20 and 40, and affects women twice as frequently as men.

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