New drugs taken orally for MS are finally here!

Finally it’s here, joining the ranks of new drugs for the treatment of Multiple Sclerosis (MS), we now have Gilenya.

The first (but not the only one) oral disease-modifying therapy drug for relapsing forms of multiple sclerosis (MS) has been approved by the Food and Drug Administration (FDA).

This med will be part of the new drugs coming out to fight MS. The pill is known generically as fingolimod. Probably the next oral med. for MS is going to be Cladribine, a pill being tested by the drug company Serono.

Since November 2004, there has not been any new disease modifying drugs approved for the treatment of Multiple Sclerosis (MS) until now. Furthermore, Gilenya is the first “First-line treatment drug to come out in over a decade. This means that as a first-line therapy any person with MS can begin taking it without previous recommendation to try other drug therapies first.

HOW DOES IT WORK

Even though no one knows for sure how Disease Modifying Drugs (DMD) work, it is believed that Gilenya blocks some blood cells in the lymph system and keeps them from going to the brain and spinal cord. The protein molecules that does that binding is so small that the gut cannot digest it and it is for this reason that Gilenya can be taken in capsule form instead of injection or infusion.

Dr. Russell Katz, M.D., Director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research, said during the FDA’s press release on Gilenya, “Gilenya is the first oral drug that can slow the progression of disability and reduce the frequency and severity of symptoms in MS, offering patients an alternative to currently available injectable therapies.”

I believe that if your current MS therapy is working fine right now, there is no reason for you to change (unless told by your doctor). Like the old saying, “If it’s not broken, don’t fix it”, there is no need to rush. Just like all new drugs, Gilenya is not without risks.

POSSIBLE SIDE EFFECTS OF GILENYA

1. Headaches
2. Flue
3. Diarrhea
4. Back pain
5. Elevation of certain liver enzymes (which could signalf liver injury)
6. Cough

In addition to the possible side effects listed above, FDA is requiring the product warning label to include potentially serious risks like:

1. decreased heart rate
2. Any and/or other heart effects after the first dose
3. Increased risk of infections
4. Risk of macular edema (swelling of the center of the retina)
5. Decrease in lung function
6. Slight increase in blood pressure
7. Risk of harm to a fetus (based on animal studies).

HOW MUCH WILL IT COST?

According to a Swiss drug industry analyst, “Gilenya will probably cost around US$ 30,000 annually”. This figure is right in the neighborhood of what it cost today any of the injectable or infused medications for MS. A healthcare analyst quoted on NPR Shots predicts that Gilenya could eventually gain about 20 percent of the MS drug market in the United States.

ADDITIONAL INFORMATION AND VIDEOS

Gilenya: What is it and How Does it Work? Video Part 1 and Part 2 from the Natioanl Multiple Sclerosis Society video library of MS Learn Online segments: Part 1, "Gilenya: What is it and How Does it Work?" and Part 2, "Gilenya: What You Should Know."

Ampyra: A New Medication to Improve Walking What is Ampyra?; How is it prescribed?; How is it administered; Is Ampyra right for me?

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