Gilenya: First Oral Treatment For Multiple Sclerosis

GilenyaThere has been a huge breakthrough in MS treatment! An oral medication by Novartis, Gilenya (formerly Gingolimod and FTY720), has finally been approved by the FDA to be available by prescription as a daily 0.5 mg capsule as a first line treatment in October.

Gilenya is an immunomodulatory drug called an S1P-receptor modulator. S1P receptors are similar to cell surface receptors on white blood cells. The drug was initially created to prevent tissue rejection following kidney transplants, but the dosage required for success was so high as to be toxic. The recommended dose for MS treatment is 5 times lower than in this initial attempt.

Essentially, this drug strips out a chemical component forcing T cells to stay in the lymph nodes where they cannot attack the central nervous system. It may also enhance repair to damaged neurons, have neuroprotective effects, and reduce whole-brain atrophy. Most treatments for MS now reduce relapses by an average of 35%. A study of Gilenya suggests a 60% reduction in relapse rate and a 74% to 82% reduction in damage as measured by MRI.

The downside to this is that there are some possible adverse side effects such as headache, flu, diarrhea, back pain, abnormal liver tests and cough. The worst possibilities are a reduction in heart rate, infrequent transient AV conduction block of the heart, increases in blood pressure; macular edema, elevated liver enzymes; and increased infections such as bronchitis and herpes. No one knows the effect of the drug on pregnancy or breastfeeding, so contraception is suggested while taking this drug. Studies so far have suggested that white blood cells return to their normal rates approximately 2 months after cessation of the drug.

Prior to starting the drug, patients need to be evaluated for baseline data on the heart, lungs, liver, eyes and vision, blood pressure, pulse, and white-blood-cell count. Patients should not take the drug if they have recently been infected by or vaccinated against chicken pox. You should be monitored for a reduction in heart rate and other side effects for 6 hours at a medical facility after your first dose

The price for Gilenya is higher than that of existing medications – $48,000 annually. Most existing treatments max out at about $38,000 annually.

When I started researching all the available data about Gilenya to write this article I was frustrated by 2 things :

  • It is virtually impossible to find all the pertinent information in any one location
  • Gilenya may also have an adverse effect on my liver.

As it stands, I suppose if and when I go off of Rebif it will probably be to Copaxone, but I would love to give this drug a try.  Enough of the facts — I’m just so excited about this – the more treatment options we have available the closer we are to a cure!

Have you had to change your MS treatment? Would you take a new drug?

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