Gilenya

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EU to rule on safety of Novartis's Gilenya MS pill

Last post by MSUK « Wed Apr 18, 2012 3:21 am

by MSUK » Wed Apr 18, 2012 3:21 am

Europe's drug regulator will likely allow Novartis AG's Gilenya to stay on the market without asking for much stricter safety warnings as it...

0 Replies

1896 Views

Last post by MSUK
Wed Apr 18, 2012 3:21 am
Oral MS drug Gilenya patient develops rare brain disease

Last post by MSUK « Fri Apr 13, 2012 2:20 am

by MSUK » Fri Apr 13, 2012 2:20 am

Novartis AG said a patient treated with its multiple-sclerosis pill Gilenya has been diagnosed with a rare and often fatal brain disease.

The Swiss...

0 Replies

2283 Views

Last post by MSUK
Fri Apr 13, 2012 2:20 am
Watchdog group wants restrictions on Gilenya for MS

Last post by MSUK « Wed Apr 11, 2012 4:49 am
Replies: 2
by MSUK » Tue Apr 10, 2012 10:34 pm

First post

The Institute for Safe Medication Practices (ISMP) is urging the US Food and Drug Administration (FDA) to put restrictions on the use of fingolimod...

Last post

or peeps can just click the link :O)

2 Replies

1975 Views

Last post by MSUK
Wed Apr 11, 2012 4:49 am
Relapse and disability outcomes in patients with MS

Last post by MSUK « Mon Apr 09, 2012 11:51 pm

by MSUK » Mon Apr 09, 2012 11:51 pm

Relapse and disability outcomes in patients with MS treated with fingolimod

Subgroup analyses of the double-blind, randomised, placebo-controlled...

0 Replies

2267 Views

Last post by MSUK
Mon Apr 09, 2012 11:51 pm
My experiences, now on Gilenya

Last post by seeva « Fri Apr 06, 2012 2:35 am
Replies: 3
by CureOrBust » Wed Nov 02, 2011 3:51 am

First post

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...

Last post

Seeva,

The Dr that prescribed me my script for Gilenya also has said that i am SPMS, and i think is the exact same Dr that will not prescribe it for...

3 Replies

5430 Views

Last post by seeva
Fri Apr 06, 2012 2:35 am
Scottish MS Society will challenge Gilenya decision

Last post by Azaeleaprawn « Wed Mar 21, 2012 6:17 pm
Replies: 1
by MSUK » Mon Mar 19, 2012 1:04 am

First post

Multiple sclerosis campaigners will step up their bid to persuade Scotland’s medicines regulator to overturn its decision to reject a new treatment...

Last post

Good on them - this drug kills.

1 Replies

1786 Views

Last post by Azaeleaprawn
Wed Mar 21, 2012 6:17 pm
Calls for Gilenya to be made available in Ireland

Last post by MSUK « Mon Mar 19, 2012 1:24 am

by MSUK » Mon Mar 19, 2012 1:24 am

The Multiple Sclerosis Society of Ireland (MS Ireland) has called on the government to make available in Ireland a controversial drug that it...

0 Replies

1843 Views

Last post by MSUK
Mon Mar 19, 2012 1:24 am
NICE backs new oral MS drug, Gilenya

Last post by MSUK « Fri Mar 16, 2012 2:59 am

by MSUK » Fri Mar 16, 2012 2:59 am

Novartis's multiple sclerosis pill Gilenya has been recommended for use on the U.K.'s publicly-funded National Health Service after a change of heart...

0 Replies

1745 Views

Last post by MSUK
Fri Mar 16, 2012 2:59 am
SMC turns down oral MS drug Gilenya

Last post by MSUK « Mon Mar 12, 2012 11:59 pm

by MSUK » Mon Mar 12, 2012 11:59 pm

The Scottish Medicines Consortium (SMC) yesterday rejected recommending the prescribing of the first oral pill for sufferers of multiple sclerosis in...

0 Replies

2122 Views

Last post by MSUK
Mon Mar 12, 2012 11:59 pm
Scottish decision due on oral MS drug Gilenya

Last post by MSUK « Mon Mar 12, 2012 12:57 am

by MSUK » Mon Mar 12, 2012 12:57 am

The Scottish Medicines Consortium (SMC) will decide on today if it will recommend the prescribing of the first oral pill for the treatment of...

0 Replies

1728 Views

Last post by MSUK
Mon Mar 12, 2012 12:57 am
Deaths hit oral MS drug, Gilenya

Last post by MSUK « Tue Mar 06, 2012 10:42 pm

by MSUK » Tue Mar 06, 2012 10:42 pm

Novartis AG's Gilenya multiple sclerosis pill lost market share for the first time in January, following the deaths of some patients soon after...

0 Replies

2555 Views

Last post by MSUK
Tue Mar 06, 2012 10:42 pm
Safety of oral MS pill Gilenya reviewed after deaths

Last post by MSUK « Tue Feb 28, 2012 3:49 am

by MSUK » Tue Feb 28, 2012 3:49 am

Health Canada is reviewing a new multiple sclerosis drug that has been linked to 11 deaths.

There have been no reports of deaths in Canada of people...

0 Replies

2243 Views

Last post by MSUK
Tue Feb 28, 2012 3:49 am
A randomized, controlled trial of fingolimod in Japanese MS

Last post by MSUK « Mon Feb 27, 2012 12:18 am

by MSUK » Mon Feb 27, 2012 12:18 am

A randomized, controlled trial of fingolimod (FTY720) in Japanese MS patients

Abstract
Background: Fingolimod (FTY720) has previously shown...

0 Replies

3187 Views

Last post by MSUK
Mon Feb 27, 2012 12:18 am
EU says MS drug Gilenya needs heart monitoring

Last post by arabia « Sat Feb 25, 2012 10:59 am
Replies: 1
by MSUK » Mon Jan 23, 2012 12:26 am

First post

The European Medicines Agency advised doctors to continuously monitor patients for six hours after giving them a first dose of Novartis AG's multiple...

Last post

thanks for sharing

1 Replies

2163 Views

Last post by arabia
Sat Feb 25, 2012 10:59 am
Oral MS drug Gilenya reviewed by EU after 11 patient deaths

Last post by MSUK « Fri Jan 20, 2012 6:05 am

by MSUK » Fri Jan 20, 2012 6:05 am

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

0 Replies

2295 Views

Last post by MSUK
Fri Jan 20, 2012 6:05 am
Death of MS patient prompts FDA Gilenya review

Last post by CureOrBust « Thu Dec 22, 2011 4:38 am
Replies: 1
by MSUK » Thu Dec 22, 2011 1:02 am

First post

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...

Last post

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...

1 Replies

2477 Views

Last post by CureOrBust
Thu Dec 22, 2011 4:38 am
Actual details on reduced Lymphocytes count?

Last post by lmacalus « Mon Dec 19, 2011 11:27 am
Replies: 3
by CureOrBust » Sun Dec 04, 2011 2:32 am

First post

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...

Last post

Have you tried calling Novartis & asking them? Could it be contained in the PI?

3 Replies

2047 Views

Last post by lmacalus
Mon Dec 19, 2011 11:27 am
6-month MRI is complete

Last post by Yash « Fri Dec 16, 2011 4:47 am
Replies: 3
by lmacalus » Sun Jul 24, 2011 4:53 pm

First post

AND THE MRI SHOWED NO NEW LESIONS & NO ACTIVE OLD STUFF!!!! SOOOOO GREAT TO BE IN REMISSION & STABLE
THANK YOU JESUS & THANK YOU GILENYA :)

next...

Last post

AND THE MRI SHOWED NO NEW LESIONS & NO ACTIVE OLD STUFF!!!! SOOOOO GREAT TO BE IN REMISSION & STABLE
THANK YOU JESUS & THANK YOU GILENYA :)

next...

3 Replies

2273 Views

Last post by Yash
Fri Dec 16, 2011 4:47 am
Gilenya® shows positive clinical outcomes in new trial

Last post by MSUK « Thu Dec 15, 2011 12:41 am

by MSUK » Thu Dec 15, 2011 12:41 am

Novartis announced today new data from the Phase III 2309 study showing patients with relapsing-remitting multiple sclerosis (RRMS) treated with...

0 Replies

1470 Views

Last post by MSUK
Thu Dec 15, 2011 12:41 am
Novartis investigating death possibly linked to Gilenya

Last post by MSUK « Mon Dec 12, 2011 11:27 pm

by MSUK » Mon Dec 12, 2011 11:27 pm

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...

0 Replies

1911 Views

Last post by MSUK
Mon Dec 12, 2011 11:27 pm
Anger at NICE oral MS drug Gilenya decision

Last post by MSUK « Tue Dec 06, 2011 12:29 am

by MSUK » Tue Dec 06, 2011 12:29 am

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...

0 Replies

1902 Views

Last post by MSUK
Tue Dec 06, 2011 12:29 am
Gilenya fails to win NICE backing in draft guidance

Last post by MSUK « Thu Dec 01, 2011 12:54 am

by MSUK » Thu Dec 01, 2011 12:54 am

The UK's health cost body National Institute for Health and Clinical Excellence, or NICE, in its revised draft guidance did not recommend Swiss...

0 Replies

1626 Views

Last post by MSUK
Thu Dec 01, 2011 12:54 am
Approved under PBS in Australia!

Last post by bateman « Sun Oct 23, 2011 8:22 pm
Replies: 8
by CureOrBust » Tue Jun 21, 2011 3:30 am

First post

It was approved under PBS in Australia today, which means in Australia it will be heavily subsidised by the Government.

Last post

Novartis are the manufacturer of Gilenya.

Your neuro should be able to advise if they have access to the drug before it is publically funded

8 Replies

3394 Views

Last post by bateman
Sun Oct 23, 2011 8:22 pm
Gilenya® shows up to 71% reduction in relapse rates

Last post by MSUK « Sun Oct 16, 2011 10:38 pm

by MSUK » Sun Oct 16, 2011 10:38 pm

Oral MS drug Gilenya® shows up to 71% reduction in annualised relapse rates

Novartis will showcase data from 13 abstracts on fingolimod...

0 Replies

1632 Views

Last post by MSUK
Sun Oct 16, 2011 10:38 pm
Gilenya, after Tysabri and CCSVI procedure

Last post by NHE « Mon Oct 03, 2011 2:55 am
Replies: 10
by SickButHappy2 » Tue Jun 21, 2011 4:02 am

First post

Hi!

I've been on Tysabri for 2 years, got my CCSVI treatment 11 months ago and now, I switched from Tysabri to Gilenya.

First, I have to say I...

Last post

I also was on Tysabri, had the ccsvi op. last Sept and will be starting my first dose of Gilenya tomorrow. The problem I'm having is I just fell into...

10 Replies

4796 Views

Last post by NHE
Mon Oct 03, 2011 2:55 am
First oral MS drug, Gilenya, rejected by NICE

Last post by mrbarlow « Wed Sep 28, 2011 2:19 pm
Replies: 3
by MSUK » Fri Aug 05, 2011 12:36 am

First post

Campaigners have expressed disappointment after the National Institute for Health and Clinical Excellence (Nice) rejected the first pill to treat...

Last post

Professor Carole Longson, director of the health technology evaluation centre at Nice, said: While it's important that people with multiple sclerosis...

3 Replies

2391 Views

Last post by mrbarlow
Wed Sep 28, 2011 2:19 pm
Japan approves Novartis’ oral MS drug Gilenya

Last post by MSUK « Wed Sep 28, 2011 12:09 am

by MSUK » Wed Sep 28, 2011 12:09 am

Japanese regulatory authorities have approved Novartis’ once-daily multiple sclerosis (MS) drug Gilenya.

The Gilenya sanction covers use of the drug...

0 Replies

1483 Views

Last post by MSUK
Wed Sep 28, 2011 12:09 am
Switching from Tysabri to Gilenya

Last post by SickButHappy2 « Sat Sep 24, 2011 3:11 am
Replies: 4
by IrinaS » Sat Jan 29, 2011 3:47 pm

First post

Does anybody know if there is a standard protocol for switching from Tysabri to Gilenya? Anybody did the switch?

Last post

They have to check also if you have antibodies of the chicken pox prior starting Gilenya.

I did the switch 4 months ago and I feel great. I didn't...

4 Replies

4571 Views

Last post by SickButHappy2
Sat Sep 24, 2011 3:11 am
Gilenya, may increase risk of macular edema in some patients

Last post by euphoniaa « Mon Sep 12, 2011 3:10 am
Replies: 1
by MSUK » Mon Sep 12, 2011 1:40 am

First post

The first U.S. Food and Drug Administration-approved oral medication for multiple sclerosis poses a potential risk of macular edema, particularly in...

Last post

The first U.S. Food and Drug Administration-approved oral medication for multiple sclerosis poses a potential risk of macular edema, particularly in...

1 Replies

2616 Views

Last post by euphoniaa
Mon Sep 12, 2011 3:10 am
FDA approves sNDA for Novartisâ€™ oral MS drug Gilenya

Last post by MSUK « Wed Aug 03, 2011 4:24 am

by MSUK » Wed Aug 03, 2011 4:24 am

Novartis Pharmaceuticals Corporation announced that the U.S. Food and Drug Administration’s approval of a supplemental New Drug Application (sNDA)...

0 Replies

1483 Views

Last post by MSUK
Wed Aug 03, 2011 4:24 am
Humble reminder

Last post by RedPepper « Sun Jul 31, 2011 11:13 pm
Replies: 11
by lmacalus » Sun Mar 13, 2011 9:03 am

First post

Humble reminder that this while doing great things IS NOT A CURE!!!
I DO feel a MILLION times better but for the past 2 days have had a couple of old...

Last post

... put me back on a pulse steroid for a couple of days. Are there any specific restrictions with this and steroids? They are from my understanding...

11 Replies

3465 Views

Last post by RedPepper
Sun Jul 31, 2011 11:13 pm
Oman licenses world's first oral drug for Multiple Sclerosis

Last post by MSUK « Mon Jul 25, 2011 6:32 am

by MSUK » Mon Jul 25, 2011 6:32 am

Oman has licensed the world's first oral medication for Multiple Sclerosis (MS), a move which medical experts say will improve medication...

0 Replies

1541 Views

Last post by MSUK
Mon Jul 25, 2011 6:32 am
First Dose

Last post by lmacalus « Sun Jul 24, 2011 4:47 pm
Replies: 1
by bill3901 » Tue Jul 19, 2011 9:29 am

First post

I have had the pills for about two weeks now and they cannot find aFirst Dose location!! It's getting very frustrating, they say it is an insurance...

Last post

Eventually the Neuro & Support team at Novartis located a cardiologist who was willing & authorized. Hang in there friend - it is well worth the wait...

1 Replies

1724 Views

Last post by lmacalus
Sun Jul 24, 2011 4:47 pm
Oral fingolimod (Gilenya) in relapsing MS

Last post by MSUK « Tue Jul 12, 2011 6:55 am

by MSUK » Tue Jul 12, 2011 6:55 am

Oral fingolimod (Gilenya) in relapsing MS: impact on health-related quality of life in a phase II study

Summary: This phase II, placebo...

0 Replies

2472 Views

Last post by MSUK
Tue Jul 12, 2011 6:55 am
NICE announces timelines for appraisal of Gilenya-fingolimod

Last post by MSUK « Mon Jul 11, 2011 6:51 am

by MSUK » Mon Jul 11, 2011 6:51 am

Following last week's meeting of the Technology Appraisal Advisory Committee for the appraisal of fingolimod (Gilenya), a new disease modifying drug...

0 Replies

1606 Views

Last post by MSUK
Mon Jul 11, 2011 6:51 am
Appraisal of GilenyaÂ® (fingolimod) by NICE begins

Last post by MSUK « Fri Jul 08, 2011 1:06 am

by MSUK » Fri Jul 08, 2011 1:06 am

NICE (The National Institute for Health and Clinical Excellence) has begun its appraisal of Gilenya® (fingolimod), a new oral medication for...

0 Replies

1495 Views

Last post by MSUK
Fri Jul 08, 2011 1:06 am
UAE licenses world's first oral medication for MS

Last post by MSUK « Mon Jun 27, 2011 6:00 am

by MSUK » Mon Jun 27, 2011 6:00 am

The UAE's Ministry of Health (MoH) has licensed the world's first oral medication for Multiple Sclerosis (MS) ensuring that the country's 1,000 MS...

0 Replies

1909 Views

Last post by MSUK
Mon Jun 27, 2011 6:00 am
Gilenya can only gain as Merck scraps rival oral MS drug

Last post by MSUK « Wed Jun 22, 2011 7:01 am

by MSUK » Wed Jun 22, 2011 7:01 am

Novartis AG's chances of eventually dominating the multibillion dollar multiple-sclerosis market with its new Gilenya pill got a boost Wednesday when...

0 Replies

1631 Views

Last post by MSUK
Wed Jun 22, 2011 7:01 am
Comparison of Gilenya with Avonex in relapsing-remitting MS

Last post by MSUK « Thu May 19, 2011 2:32 am

by MSUK » Thu May 19, 2011 2:32 am

Summary

Background

In a 12-month phase 3 study in patients with relapsing-remitting multiple sclerosis (RRMS), TRANSFORMS, fingolimod showed...

0 Replies

2069 Views

Last post by MSUK
Thu May 19, 2011 2:32 am
Cardiovascular effects of oral MS drug Gilenya transient

Last post by MSUK « Thu May 19, 2011 2:17 am

by MSUK » Thu May 19, 2011 2:17 am

Cardiovascular effects of oral MS drug Gilenya mostly transient

The first approved oral medication for multiple sclerosis causes transient...

0 Replies

1844 Views

Last post by MSUK
Thu May 19, 2011 2:17 am
just an article....

Last post by sou « Wed May 11, 2011 12:55 pm
Replies: 2
by scorpion » Mon Jan 17, 2011 11:08 am

2 Replies

2005 Views

Last post by sou
Wed May 11, 2011 12:55 pm
Reducing the side effects of MS drug, Gilenya

Last post by MSUK « Tue May 10, 2011 12:28 am

by MSUK » Tue May 10, 2011 12:28 am

The drug Gilenya (FTY720) is approved for the treatment of multiple sclerosis. Although highly effective it can have serious side effects, including...

0 Replies

2314 Views

Last post by MSUK
Tue May 10, 2011 12:28 am
Oral MS drug Gilenya has yet to show â€˜full potential'

Last post by MSUK « Wed Apr 27, 2011 11:50 pm

by MSUK » Wed Apr 27, 2011 11:50 pm

Novartis's multiple sclerosis pill Gilenya, which faces a threat from a rival product under development by Biogen Idec Inc, has yet to show its full...

0 Replies

1609 Views

Last post by MSUK
Wed Apr 27, 2011 11:50 pm
First oral MS drug, Gilenya, now available in UK

Last post by MSUK « Mon Apr 18, 2011 10:51 pm

by MSUK » Mon Apr 18, 2011 10:51 pm

A new drug for multiple sclerosis that is twice as effective as the current standard treatment is now available in the UK.

Fingolimod - also known...

0 Replies

1878 Views

Last post by MSUK
Mon Apr 18, 2011 10:51 pm
Gilenya reduced the risk of MS disability progression

Last post by MSUK « Mon Apr 11, 2011 2:26 am

by MSUK » Mon Apr 11, 2011 2:26 am

Gilenya reduced the risk of MS disability progression regardless of treatment history or disease severity

A new analysis demonstrated that...

0 Replies

1812 Views

Last post by MSUK
Mon Apr 11, 2011 2:26 am
Dubai health authority backs new oral medication for MS

Last post by MSUK « Wed Mar 23, 2011 2:49 am

by MSUK » Wed Mar 23, 2011 2:49 am

The UAE's Multiple Sclerosis (MS) community is set to become the first in the region to benefit from a new oral medication designed to reduce...

0 Replies

2005 Views

Last post by MSUK
Wed Mar 23, 2011 2:49 am
Gilenya, the first oral MS treatment, approved in Europe

Last post by MSUK « Mon Mar 21, 2011 8:16 am

by MSUK » Mon Mar 21, 2011 8:16 am

The European Commission has granted Novartis approval for Gilenya® (fingolimod) 0.5 mg daily as a disease modifying therapy in patients with highly...

0 Replies

1879 Views

Last post by MSUK
Mon Mar 21, 2011 8:16 am
Gilenya Effects on the CNS

Last post by lmacalus « Wed Mar 09, 2011 2:20 pm
Replies: 3
by Chilax » Wed Jan 05, 2011 2:26 pm

First post

A team from The Scripps Research Institute has recently discovered that Gilenya's success may involve an unexpected biological mechanism acting...

Last post

This could be a HUGE fringe benefit of taking this. I haven't suffered badly from nerve death yet, but fewer relapses less severe relapses & nerve...

3 Replies

4321 Views

Last post by lmacalus
Wed Mar 09, 2011 2:20 pm
Week #2

Last post by lmacalus « Wed Feb 16, 2011 4:05 pm
Replies: 2
by lmacalus » Tue Feb 08, 2011 2:24 pm

First post

So it's off to a good start! Still sleeping great & waking at normal hours feeling rested & ready to go. Noticing that bladder & bowl functions have...

Last post

K so keeping up with 2 posts getting tricky - going to stay with the first thread & discontinue this one :o)

2 Replies

2145 Views

Last post by lmacalus
Wed Feb 16, 2011 4:05 pm
Gilenya Usage History

Last post by Chilax « Sun Jan 30, 2011 4:13 pm
Replies: 14
by Chilax » Wed Dec 15, 2010 4:54 am

First post

Hi,

I was dx'd in October and will be starting Gilenya soon after I complete my pre-med tests (i.e., blood work, EKG, neuro-optholmologice exam,...

Last post

Laura,

Based on the Gilenya Phase III study the skin cancer occurrences were way too few to include in any FDA warning. The majority were basal...

14 Replies

7181 Views

Last post by Chilax
Sun Jan 30, 2011 4:13 pm

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