FDA Approves a Pill for Multiple Sclerosis

November 5th, 2010 | Sources: BurrillReport

The FDA has approved Gilenya for use in slowing the progression of multiple sclerosis and reducing the frequency of disease relapses. The drug, developed by Novartis, becomes the first federally approved oral treatment for the debilitating disease, which affects 400,000 people in the US and more than 2 million people around the world.

Novartis had been in a race with Merck to be first-to-market with an effective oral treatment for multiple sclerosis, a disease that attacks the central nervous system and causes symptoms ranging from double vision to gait abnormalities and even stroke-like symptoms.

Marck’s anti-MS drug, cladribine, will be reviewed and possibly approved by the FDA before the end of this year.

Industry analysts and Novartis expect Gilenya to achieve at least $1 billion in annual sales.

Until the FDA green-lighted Gilenya, the only FDA-approved options for MS patients were intravenous drugs produced by Biogen Idec and Bayer. Biogen’s products, Avonex and Tysabri are leaders in MS market, which is estimated to be worth $8.6 billion per year.

“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,” Nicholas LaRocca, a VP at the National Multiple Sclerosis Society told BurrillReport.

In approving Gilenya, the FDA warned that patients who take the drug should be observed for slow heart rates shortly after therapy begins, and that the drug may be associated with infections.

For its part, Biogen Idec added in a statement that the long-term safety of Gilenya “has yet to be established.”

The mechanism of action of Gilenya remains unknown.  Many scientists believe it modulates a pathologic tendency for the body’s white blood cells to attack myelin, a fat-like substance that forms a protective sheath around nerve cells.


 

Comments

  1. pharmacy technician | 8/11/10

    Great information! I’ve been looking for something like this for a while now. Thanks!

  2. Jane | 2/05/11

    I’ve had several family members (on my dads side) die of MS, so this is wonderful news. Back then, there were no treatments really. Hopefully the side affects of Novartis don’t negate the benefits of using it though..

  3. Raymond | 3/08/11

    Working in a pharmacy, I see many new drugs hit the shelf daily. All claiming that they have found a magical cure. What upsets me is that these drug companies make this miracle drug, and then turn around a slap a price tag on it that only people that are a part of the rich and famous can afford.

    @the drug companies…If you want to be considered a hero, make your prices afforable so that if not all at least most people can afford and benefit from them.

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