June 13, 2010

Novartis Multiple Sclerosis Pill Gilenia Wins Advisory Panel Approval


This is nothing short of great news within the medical community in the United States in particular, but worldwide in general, as the first oral pill designed to treat multiple sclerosis is on its way to final approval from the United States FDA.

An advisory committee approved the drug, and now it is in the hands of the FDA to make the final decision.

Typically, the FDA follows recommendations from the committee. The advisory panel is made up of experts who are not directly affiliated with the FDA.

The pill will be marketed with the name Gilenia. The pharmaceutical name is fingolimod and manufactured by Novartis.

The panel was skeptical about the approval because of a number of serious side effects associated with the pill including decreased lung function and heart problems.

However, they based their approval decision on the fact that the benefits outweigh the risks.

Novartis will continue with a five year study examining the long term side effects of the pill.

Now it is up to the FDA to decide if the benefits are worth it.

The decision is expected to come by September of this year. If approved, the pill is expected to generate a billion dollars in annual sales for the company.

Several other drug manufacturer’s have also been working on similar oral pills and are working on getting their versions approved for use in the US.

The pill is expected to help delay the symptoms associated with the onset of multiple sclerosis.

The disease usually attacks people in their 20s and progressively gets worse.

The disease affects the nervous system and often results in the sufferer being unable to walk or talk.

Related: What is Multiple Sclerosis?

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