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Gilenya, or Fingolimod, is the first approved oral disease modifying drug for MS.

Oral MS drug Gilenya reviewed by EU after 11 patient deaths

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The European Medicines Agency started a review of Novartis AG’s Gilenya pill for multiple sclerosis after 11 deaths among patients who received treatment.

The reports raise concern that the drug, the first oral medicine for the debilitating neurological disease, may harm the heart, the London-based agency said in an e-mailed statement today. Eric Althoff, a spokesman for Novartis in Basel, Switzerland, didn’t immediately return a call and e-mail requesting comment.

Novartis said last month ...
Read more : Oral MS drug Gilenya reviewed by EU after 11 patient deaths | Views : 1489 | Replies : 0


Death of MS patient prompts FDA Gilenya review

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The death of a multiple sclerosis patient shortly after a first dose of fingolimod (Gilenya) is under review by the FDA, the agency said.

No specific cause of death has been determined in the case, which occurred on Nov. 23, and the FDA emphasized that it had not ascertained that the drug was related to the fatal outcome.

Fingolimod's prescribing information includes a warning about bradycardia and/or atrioventricular conduction block in the first hours ...
Read more : Death of MS patient prompts FDA Gilenya review | Views : 1718 | Replies : 1


Gilenya® shows positive clinical outcomes in new trial

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Novartis announced today new data from the Phase III 2309 study showing patients with relapsing-remitting multiple sclerosis (RRMS) treated with Gilenya® (fingolimod) had a statistically significant 48% reduction in annualized relapse rates (ARR) at 24 months compared to placebo. Study 2309 is the third Phase III clinical trial to demonstrate a significant reduction of relapse rates with Gilenya treatment in patients with RRMS.

The two previous Gilenya studies involved a two-year, placebo-controlled trial and ...
Read more : Gilenya® shows positive clinical outcomes in new trial | Views : 821 | Replies : 0


Novartis investigating death possibly linked to Gilenya

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One year after Novartis won FDA approval for a new type of drug to treat relapsing forms of multiple sclerosis and delay the progression of physical disabilities, the drugmaker is now investigating a death tied to its pill, which is called Gilenya. The disclosure, which was made by a Wall Street analyst, has the potential to cast a pall over a drug that has been expected to generate blockbuster sales.

Specifically, this is the ...
Read more : Novartis investigating death possibly linked to Gilenya | Views : 1232 | Replies : 0


Anger at NICE oral MS drug Gilenya decision

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Campaigners have condemned a decision that could lead to a ban on the use of the first pill to treat multiple sclerosis.

The National Institute of Health and Clinical Excellence (NICE) ruled the drug was too expensive following a second consultation on its use.

It says it is not minded to make it available on the NHS but a final decision has not been made yet and people can still make their views known. ...
Read more : Anger at NICE oral MS drug Gilenya decision | Views : 1246 | Replies : 0


Actual details on reduced Lymphocytes count?

I tried doing a search to find the actual numeric effects on cell counts of circulating Lymphocytes before and after being on Gilenya. I didn't find it. The best I found was an approximation for mice in an experiment, who I would assume would of been on much more severe doses.

I would love to see the data from the Phase II and Phase III trials; which used different dosages? Is this data available anywhere? ...
Read more : Actual details on reduced Lymphocytes count? | Views : 1329 | Replies : 3


Gilenya fails to win NICE backing in draft guidance

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The UK's health cost body National Institute for Health and Clinical Excellence, or NICE, in its revised draft guidance did not recommend Swiss pharmaceutical giant Novartis' multiple sclerosis pill Gilenya, as it believes the drug would not be cost effective for the National Health Service, or NHS, in comparison with other available treatments. NICE has not yet issued guidance for the NHS.

Gilenya, or fingolimod, is a daily capsule that could reduce relapses in ...
Read more : Gilenya fails to win NICE backing in draft guidance | Views : 1035 | Replies : 0


Day 4 on Gilenya

I started Gilenya on Saturday. I don't know what I was expecting. I was a little fatigued the first couple of days. Other than that nothing has happened, good or bad. Just a not for anyone interested in starting.
Read more : Day 4 on Gilenya | Views : 3161 | Replies : 4


My experiences, now on Gilenya

First a little context / history.

I have had 3 CCSVI procedures, with little to no relief. I have tried ABX's, I was initially on REBIF, which failed for me. I have had MS Symptoms for around 15 years, with a diagnosis of MS for the past 8 years. I have two neurologists, with one saying SPMS, and the other saying RR. My EDSS is about 4.0 or higher. I can walk just over 1km. ...
Read more : My experiences, now on Gilenya | Views : 3485 | Replies : 3


Gilenya and LDN

Hi, to the forum:

Has anyone been thinking of taking both Gilenya and LDN?
Does anyone know if there are contraindications?
What a dilemma*
I would love to talk about it

Regards everyone.
Read more : Gilenya and LDN | Views : 3553 | Replies : 3


 

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