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Novartis Gets FDA Approval on First Oral Multiple Sclerosis Drug - Gilenya

Posted Sep 22 2010 5:15pm

This has to be a welcome sigh for sufferers of MS with now being able to take a pill versus injections and I might guess it will be high demand being the first oral drug to image treat MS.  It’s not a cure but helps by reducing circulation and entry into the brain of immune cells that cause damage to the brain.

In clinical trials patients had around half of the number of relapses.  It appears to be about the same as far as results of drugs that are injected, but again I think swallowing  a pill will be a much welcome change. 

The National Multiple Sclerosis Website has quite a bit of information about the approval and recommended use.  BD

A failed anti-rejection drug got a new purpose and a new lease on commercial life Wednesday as the Food and Drug Administration image approved the medication fingolimod -- to be marketed as Gilenya -- to slow the progression of disability in multiple sclerosis patients.
Gilenya becomes the first MS medication that can be taken daily in pill form, and it joins a small clutch of injectable medications that sometimes go unused because they can be difficult to administer and have bothersome or painful side effects, including flulike symptoms and pain at the site of injection.

The Swiss drug giant Novartis , which makes Gilenya, had already abandoned its effort to seek FDA approval of a higher dose of the drug, after several clinical trials found it raised the rate of serious side effects without offering patients greater improvement in their symptoms.
The newly approved drug works differently than other MS therapies currently in use. It reduces the circulation and the penetration into the brain of immune cells that cause inflammatory damage to brain cells and the fatty sheaths that protect the connections between them. In relapsing-remitting multiple sclerosis, which accounts for the majority of cases worldwide, episodes of inflammation in the brain leave lesions that can result in progressively disabling problems with mobility and cognition.

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