A Blockbuster in Due Time

No surprise here. Novartis' (NYSE: NVS  ) oral multiple sclerosis drug Gilenya received Food and Drug Administration approval as expected yesterday.

OK, perhaps there was one surprise: The drug's name changed from Gilenia to Gilenya. But that shouldn't come as too big of a surprise since the spelling with a y is what Novartis is using in Russia, where it's already approved.

While an approval was widely expected after a unanimous positive recommendation from an FDA advisory panel, sales of Gilenya are still a big mystery.

Gilenya is the first oral drug used to slow down relapses in multiple sclerosis patients. The other drugs from Bayer, Merck KGaA, Pfizer (NYSE: PFE  ) , Teva Pharmaceutical (Nasdaq: TEVA  ) , Biogen Idec, and Elan (NYSE: ELN  ) have to be injected or infused.

Acorda Therapeutics' (Nasdaq: ACOR  ) Ampyra is taken orally, but it's designed to help multiple sclerosis patients walk, not slow down the disease's progression.

My fellow Fool Jordan DiPietro is excited about Gilenya. His mom has multiple sclerosis, and they've been looking forward to the availability of the drug for a while.

I'm a little more reserved. Doctors will prescribe Gilenya for sure. There are patients who aren't taking medication simply because of their disdain for needles. But I have a hard time seeing a mass exodus from the proven drugs toward one that has only been tested on a limited number of patients. Gilenya exhibited side effects in the clinical trials, and doctors will likely want to get real life experience -- in the aforementioned trypanophobiacs -- before prescribing Gilenya to the masses.

There's also the issue of competing oral drugs coming down the pipeline. Merck KGaA has one currently up for FDA review, and Biogen, Teva, and sanofi-aventis (NYSE: SNY  ) are also working on oral drugs. Depending on how the efficacy and safety profiles look for those drugs, Gilenya could end up peaking earlier than expected as more oral drugs make it to market. That could end up being the biggest surprise of all.

True to its name, The Motley Fool is made up of a motley assortment of writers and analysts, each with a unique perspective; sometimes we agree, sometimes we disagree, but we all believe in the power of learning from each other through our Foolish community. Have an opinion about Gilenya that's different from Brian's or Jordan's? Leave it in the comment box below.

Novartis is a Motley Fool Global Gains recommendation. Pfizer is a Motley Fool Inside Value recommendation. Elan is a Motley Fool Rule Breakers pick. Try any of our Foolish newsletter services free for 30 days.

Fool contributor Brian Orelli, Ph.D., doesn't own shares of any company mentioned in this article. The Fool owns shares of Teva Pharmaceutical and has a disclosure policy.


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