[Natalie8]

I posted part of this in my comments on the Tysabri thread but thought I would post here too. I learned interesting things about Fingolimod today after visiting with my neurologist. They are not going to keep the name Gilenia which had been originally assigned to replace the name fingolimod. A new one has not been chosen yet. He spoke to Novartis and I think he said it will be approved Sept. 21 (if FDA says yes, but likely will). It probably won't become available to dispense in pharmacies until Oct. or Nov. Apparently there is an issue going on with the insurance companies and whether they will reimburse for it because it is new (and may be considered second line treatment). Or it may be reimbursed since it is "technically" the first pill. But the Ampyra pills for walking are also complicating the argument that it is the first pill. He spoke fairly positively about the drug. Of course he said we don't know what the long term implications are of imuno-suppression with fingolimod but I did not get strong opposition from him. The general side effect profile looks minimal for day to day feelings (no nausea, dizziness, fatigue...that kind of stuff). It slows your heart beat by about 10 only on the first dose so he will keep his patients in the office for the first 6 hours to observe if they have low heart beats to begin with. Initially they were worried about lung capacity diminishing but he said that didn't really show up in any statistically meaningful way. There have been 6 cases of macular edema, 5 have resolved after going off the drug. He will have his patients checked by an opthamologist regularly. He will also recommend skin checks regularly since a few people got basal cell skin cancer. He said the other concern is herpes as two cases led to death in the patients--herpes encephalitis and herpes zoster (which is chicken pox). In both cases he said treatment was significantly delayed which may have contributed to death. He is not as worried about herpes infections because we have antivirals that work specifically on the herpes virus. He would also run blood tests on patients just to gauge which herpes viruses they carry in their bodies--I guess for monitoring reasons.

My neuro said there may be some evidence for neuroprotection with fingolimod in addition to just suppressing the immune system. The original trial started with 5 mg. and the prescribing dose will be .5 mg.

Generally speaking, he won't recommend fingolimod as a first line drug until after 2 years of seeing what will show up. But, he is not adverse to prescribing it if someone couldn't tolerate interferons or copaxone. If he had to choose between Tysabri and fingolimod as a second-line treatment specifically tested for MS, as much as he loves Tysabri's success, he feels the safety record is slightly better with the unknown relatively new fingolimod v. the possible PML with Tysabri. But again, he seemed open to letting the patient make this choice based on their tolerance to different kinds of risk. He did not seem alarmist about this drug. I know he is far more worried about cladribine pills which may come out soon because cancer risks are much higher (like lymphoma) and unlike fingolimod you can't reconstitute your immune system quickly if you have to just by stopping the drug.