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

FDA issues new advice on oral MS drug Gilenya

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As their European counterparts did last month, the FDA has recommended continued use of the Gilenya multiple sclerosis pill sold by Novartis, but did say the drug should carry stronger warnings about heart risks and that some patients should undergo increased monitoring. The move was largely expected after the European Medicines Agency issued a similar alert, despite arguments by a non-profit safety watchdog that further restrictions are needed.

Although cardiovascular risks were known at ...
Read more : FDA issues new advice on oral MS drug Gilenya | Views : 1892 | Replies : 0


cost?

Hello all

sorry.. as i am sure this has been addressed before- but this is a new topic to me--what does everyone pay for gilenya--
seems to me here in Calgary it's about $2600. a month-- are there any subsidies available.?. how do people ( average people with average jobs afford this med?)

any info would be appreciated
thanks
Andie
Read more : cost? | Views : 1721 | Replies : 1


New MS oral drug, Gilenya, still not available in Eire

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A new oral drug to treat the symptoms of Multiple Sclerosis, which has been licensed and deemed cost-effective here, remains unavailable to sufferers.

The final stage in the HSE’s process before which it could be prescribed was “neither fair nor transparent”, a leading neurologist has said.

Prof Orla Hardiman, consultant neurologist at Beaumont Hospital in Dublin, said the MS drug Gilenya had been assessed and deemed cost-effective at the National Centre for Pharmacoeconomics (NCPE) ...
Read more : New MS oral drug, Gilenya, still not available in Eire | Views : 1670 | Replies : 0


first (and last) dose

I just took a dose of Gilenya in Los Angeles. Background: I was on ABCRs for seven years, dropped Avonex around New Year's due to a breakthrough relapse, went on Tysabri but had to leave because I had developed antibodies. After a frustrating two months without treatment, I finally got on Gilenya last night.

In the screening process, I learned that I have an unusually low heart rate (probably due to good overall cardio health ...
Read more : first (and last) dose | Views : 2367 | Replies : 0


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 : 1491 | 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 : 1521 | 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 : 1209 | 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 : 1625 | 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 : 1428 | 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 : 1665 | Replies : 0


 

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