new information on Gilenia (Fingolimod)
 

The FDA met on June 10 regarding the approval of Ginlenia, the first oral pill for MS. The advisory board voted 25-0 to recommend approval. The FDA usually follows this board's advice when giving the final green light. They have postponed sale of it for 3 more months until September to think about safety measures since the drug is a new entity. It looks like we may have these pills by fall.

These articles have very useful information.

http://m.industry.bnet.com/pharma/10...-drug-gilenia/

http://cenblog.org/the-haystack/2010...e-green-light/

http://www.webmd.com/multiple-sclero...t-oral-ms-drug

Thanks for posting this Natalie!

The FDA usually follows the recommendation of the advisory committee, but not always. There are a lot of safety concerns with this drug, but the advisory committee voted to approve because with monitoring, they feel the benefits will outweigh the risks shown in study information. The FDA may require a trial for an 0.25 mg dose to be run to see if a lower dose is less risky, if they approve the 0.5 mg dose. It's thought that they may require a program similar to "Touch" for approval. Hopefully no weird stuff pops up after approval!!

It looks like orals may actually be here! :)

Bumpity bump...

I'm wondering...just what are the risks?

I spoke to my MS neuro about the new orals and he thinks I should stay with Copaxone since it's working for me. Why fix it if it isn't broken?

Anyway, I hope this will give a good alternative for many of us who are tired of shots or infusions. The MS pills are finally on the horizon!! :)

nOT SURE, BLOOD PRESSURE, LIVER ENZYMES AND STUFF i THINK. bUT EVERY DRUg COMES WITH A SLEW OF SIDE EFFECTS ATTACHED, WANT TO TRY THIS ONE. Novantrone and 4-Ap came with scary ones. It's in clinical trial for PPMS. Because I could not walk, trial would not accept me. I'm 54, in a chair, option to wait longer doesn't exist. Hope to get prescription and try,will pay for drug myself.

liver toxicity, bradycardia, heart conduction abnormalities,
macular edema, gradual decline in pulmonary function
pulmonary toxicity, serious herpes infections

The studies excluded patients with diabetes, heart conduction disorders,arrhythmias and pulmonary disease
(cardiac toxicities are of particular concern given the known effect of S1P modulation on heart rate)

The advisory panel suggested that a six hour observation period for at least the first dose be established as a condition of approval due to the cardiac problems seen in studies and that further studies are needed for people who were excluded from the studies due to the above conditions.

Like any other drug, there are risks.

Scary. I hate drugs and decisions. And MS.