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

EU supports oral MS drug, Gilenya, with stronger warning

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European regulators have endorsed the continued use of Novartis AG's multiple sclerosis pill Gilenya, one of the Swiss firm's top new drug hopes, but said on Friday the drug needed to carry stronger warnings on heart risks.

Novartis said the decision meant the drug remained on-track to be a "blockbuster" - one with annual sales above $1 billion.

Prospects for Gilenya, the first multiple sclerosis (MS) pill of its kind, have been clouded by ...
Read more : EU supports oral MS drug, Gilenya, with stronger warning | Views : 1431 | Replies : 0


7 year extension data for Gilenya

Extension study data for Gilenya® shows patients successfully treated for up to 7 years

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New data will be presented at the 64th annual meeting of the American Academy of Neurology (AAN) that support the efficacy and safety profile of Gilenya® (fingolimod), the only oral therapy approved to treat relapsing forms of multiple sclerosis (MS).

"The data being presented reinforce our confidence in the sustained efficacy and safety profile of Gilenya," said David Epstein, Head ...
Read more : 7 year extension data for Gilenya | Views : 1460 | Replies : 0


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

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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 concludes a review of the multiple sclerosis pill initiated after reports of heart problems and the death of a patient who took the drug.

The regulator's decision could come as early as Thursday, said the London-based European Medicines Agency, the body responsible for licensing Gilenya in Europe a year ago.

The ...
Read more : EU to rule on safety of Novartis's Gilenya MS pill | Views : 1149 | Replies : 0


Oral MS drug Gilenya patient develops rare brain disease

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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 drug maker said the patient had been previously treated with another MS drug, Tysabri, co-marketed by Biogen Idec Inc. and Elan Corp. PLC, which has been already associated with progressive multifocal leukoencephalopathy.

"The current assessment is that Tysabri is the drug most likely associated with this case of PML," Novartis ...
Read more : Oral MS drug Gilenya patient develops rare brain disease | Views : 1548 | Replies : 0


Watchdog group wants restrictions on Gilenya for MS

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The Institute for Safe Medication Practices (ISMP) is urging the US Food and Drug Administration (FDA) to put restrictions on the use of fingolimod (Gilenya, Novartis) in patients with multiple sclerosis (MS), owing to postmarketing adverse event reports.

"Problems of widespread toxicity that were already evident in clinical testing of fingolimod are now producing strong signals in the postmarket adverse event data," the nonprofit group says in a new report.

The ISMP sifted through ...
Read more : Watchdog group wants restrictions on Gilenya for MS | Views : 1375 | Replies : 2


Relapse and disability outcomes in patients with MS

Relapse and disability outcomes in patients with MS treated with fingolimod

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Subgroup analyses of the double-blind, randomised, placebo-controlled FREEDOMS study

Summary

Background
Fingolimod 0·5 mg once daily is approved for treatment of relapsing multiple sclerosis (MS). In the phase 3, 2-year FREEDOMS (FTY720 Research Evaluating Effects of Daily Oral therapy in MS) study, fingolimod significantly reduced annualised relapse rates (ARRs) and the risk of confirmed disability progression compared with placebo. We aimed to investigate ...
Read more : Relapse and disability outcomes in patients with MS | Views : 1593 | Replies : 0


A severe side effect response to gilenya

https://www.facebook.com/notes/ccsvi-in ... 5834334919

A Canadians first dose: "Well unfortunately it did not go well. My blood pressure dropped so quickly, to 30 bpm they sent me to VGH and after, every Doctor and their dog came to see me, as they are unfamiliar with Gilenya.

They had to call Poison Control. That's where the ER Doctors had to get the info.

I spent 26 hours in the Cardiac Care ...
Read more : A severe side effect response to gilenya | Views : 3737 | Replies : 11


MSRC Launch Gilenya User Diaries

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MSRC Launch Gilenya User Diaries.

Following on from the success of our Tysabri User Diaries in providing personal experiences of MSers on a drug, MSRC have today launched a new facility for those taking, or thinking of taking Gilenya, the first approved oral MS medication. http://www.msrc.co.uk/index.cfm/fuseact ... geid/3403/

Kim has become our first diarist and you can read her page at http://www.msrc.co.uk/index.cfm/fuseact ... ageid/3404 ...
Read more : MSRC Launch Gilenya User Diaries | Views : 2188 | Replies : 7


Calls for Gilenya to be made available in Ireland

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The Multiple Sclerosis Society of Ireland (MS Ireland) has called on the government to make available in Ireland a controversial drug that it believes would much more effectively treat some forms of the disease.

The call, echoed by the drug’s manufacturer, follows the decision by the National Institute for Health and Clinical Excellence (NICE) in the UK to recommend that the drug, fingolimod - known by its brand name Gilenya - , be available ...
Read more : Calls for Gilenya to be made available in Ireland | Views : 1221 | Replies : 0


Scottish MS Society will challenge Gilenya decision

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

The Multiple Sclerosis Society Scotland yesterday said it would be writing to the Scottish Medicines Consortium (SMC) to try to convince the regulator it should approve the use of fingolimod.

Pressure mounted on the SMC after its equivalent body south of the Border, the National Institute for Health and ...
Read more : Scottish MS Society will challenge Gilenya decision | Views : 1199 | Replies : 1


 

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