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

First oral MS drug, Gilenya, rejected by NICE

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

The MS Society urged the medicines watchdog and drug firm Novartis to work together so that Gilenya – also called fingolimod – can be reappraised.

In draft guidance which is subject to consultation, Nice rejected the drug due to "uncertainties" over its effectiveness, a lack of appropriate data and concerns over cost-effectiveness. ...
Read more : First oral MS drug, Gilenya, rejected by NICE | Views : 1637 | Replies : 3


FDA approves sNDA for Novartis’ oral MS drug Gilenya

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Novartis Pharmaceuticals Corporation announced that the U.S. Food and Drug Administration’s approval of a supplemental New Drug Application (sNDA) for Gilenya™ (fingolimod) that includes T1 Gd-enhancing magnetic resonance imaging (MRI) data. Gilenya is a prescription medicine used to treat relapsing forms of multiple sclerosis (MS) in adults. It can decrease the number of MS flare-ups (relapses). It does not cure MS but can help slow down the physical problems that MS causes.

T1 Gd-enhancing ...
Read more : FDA approves sNDA for Novartis’ oral MS drug Gilenya | Views : 874 | Replies : 0


Oman licenses world's first oral drug for Multiple Sclerosis

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Oman has licensed the world's first oral medication for Multiple Sclerosis (MS), a move which medical experts say will improve medication tolerability and compliance for many of Oman's 200 MS sufferers.

The Oman Ministry of Health has approved the Novartis-made drug Gilenya (fingolimod) for use in the relapsing remitting form of MS that affects around two-thirds of those diagnosed with the disease, which causes muscle weakness, problems with coordination and impaired concentration.

Making the ...
Read more : Oman licenses world's first oral drug for Multiple Sclerosis | Views : 919 | Replies : 0


6-month MRI is complete

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 MRI in 6 mos (for my 1 year Anniversary)

Symptoms really not apparent, strength good & building, heat sensitvity reduced but still there a bit (easily managed)
Bowel, bladder, sleep patterns & vision all normal & functioning normally. ...
Read more : 6-month MRI is complete | Views : 1662 | Replies : 3


First Dose

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 thing but I have BCBS and I have Medicaid and that cobination covered the pills 100%
I calling my neuro and Gilenya but they are not finding anything.
It is bothering me so much cause I am building this drug up in my head now!
Read more : First Dose | Views : 1013 | Replies : 1


Oral fingolimod (Gilenya) in relapsing MS

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

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Summary: This phase II, placebo controlled study in relapsing MS from Spain reports on the effects of treatment with fingolimod (Gilenya) on patient’s quality of life.

Data from the study supports a clinically important effect of fingolimod on health-related quality of life scores and on the fatigue/thinking HAQUAMS sub-domain. Similarly, BDI-II scores indicative of clinical depression favoured ...
Read more : Oral fingolimod (Gilenya) in relapsing MS | Views : 1819 | Replies : 0


NICE announces timelines for appraisal of Gilenya-fingolimod

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Following last week's meeting of the Technology Appraisal Advisory Committee for the appraisal of fingolimod (Gilenya), a new disease modifying drug for relapsing remitting MS, NICE (National Institute for Health and Clinical Excellence) has announced the following timelines:

If an Appraisal Consultation Document (ACD) is issued, it will be released during the week commencing Monday 25 July.
If a Final Appraisal Determination (FAD) is issued, it will be released during the week commencing Monday ...
Read more : NICE announces timelines for appraisal of Gilenya-fingolimod | Views : 1023 | Replies : 0


Appraisal of Gilenya® (fingolimod) by NICE begins

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

Fingolimod was granted a licence by the EMA (European Medicines Agency) in March 2011. The appraisal by NICE is to decide whether it should be funded by the NHS.

Gilenya® (fingolimod) is the first in a new class of disease-modifying treatments called sphingosine 1-phosphate receptor (S1P-R) modulators and has a ...
Read more : Appraisal of Gilenya® (fingolimod) by NICE begins | Views : 913 | Replies : 0


UAE licenses world's first oral medication for MS

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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 sufferers have fast access to the latest medications that will change the treatment of MS, it was announced at a press conference today.

The MoH has approved the Novartis-made drug GilenyaTM (fingolimod) for use in the relapsing remitting form of MS that affects around two-thirds of those diagnosed with the disease, ...
Read more : UAE licenses world's first oral medication for MS | Views : 984 | Replies : 0


Gilenya can only gain as Merck scraps rival oral MS drug

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Novartis AG's chances of eventually dominating the multibillion dollar multiple-sclerosis market with its new Gilenya pill got a boost Wednesday when Merck KGaA of Germany abandoned attempts to market a rival treatment.

Merck's decision to stop market applications for its MS medicine cladribine and pull the product from Russia and Australia—which comes after the U.S. Food and Drug Administration required more testing to allay safety concerns—means Novartis has the only oral multiple-sclerosis treatment in ...
Read more : Gilenya can only gain as Merck scraps rival oral MS drug | Views : 1011 | Replies : 0


 

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