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

NICE backs new oral MS drug, Gilenya

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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 by the country's healthcare cost-effectiveness watchdog.

Friday's verdict from the National Institute for Health and Clinical Excellence, whose opinions are also watched closely in other countries, is welcome news for the Swiss company's potential blockbuster product whose safety profile has come into question recently.

NICE said it changed its mind on the ...
Read more : NICE backs new oral MS drug, Gilenya | Views : 1120 | Replies : 0


SMC turns down oral MS drug Gilenya

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

The SMC said that, while the manufacturers of Gilenya, had provided evidence about it helping to reduce relapse rates, they had not compared it with another drug commonly used in Scotland.

It added that evidence showed that starting treatment with Fingolimod could cause a short-term decrease in heart rate and swelling of ...
Read more : SMC turns down oral MS drug Gilenya | Views : 1476 | Replies : 0


Scottish decision due on oral MS drug Gilenya

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

Currently, suffers face painful daily injections deep into the muscle or having to travel to hospital for infusion therapy to try to control the disease, which damages the central nervous system, causing a range of disabilities such as problems with co-ordination, speech and vision.

But this ...
Read more : Scottish decision due on oral MS drug Gilenya | Views : 1081 | Replies : 0


Deaths hit oral MS drug, Gilenya

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

Gilenya's share of the U.S. market for so-called immunomodulatory drugs against MS fell to 6.1 percent from 6.2 percent in December, according to data from Wolters Kluwer NV, a market research company. The decline was the first after 15 ...
Read more : Deaths hit oral MS drug, Gilenya | Views : 1793 | Replies : 0


Safety of oral MS pill Gilenya reviewed after deaths

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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 taking the Novartis drug, which is sold under the brand name Gilenya.

Health Canada says that of the deaths outside the country, it's not clear whether the drug itself caused them, or whether other factors played a role.

Both the U.S. Food and Drug Administration and the ...
Read more : Safety of oral MS pill Gilenya reviewed after deaths | Views : 1540 | Replies : 0


A randomized, controlled trial of fingolimod in Japanese MS

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

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Abstract
Background: Fingolimod (FTY720) has previously shown clinical efficacy in phase II/III studies of predominantly Caucasian populations with multiple sclerosis (MS).

Objectives: To report six-month efficacy and safety outcomes in Japanese patients with relapsing MS treated with fingolimod.... Read More - http://www.msrc.co.uk/index.cfm/fuseact ... ageid/1309
Read more : A randomized, controlled trial of fingolimod in Japanese MS | Views : 1614 | Replies : 0


EU says MS drug Gilenya needs heart monitoring

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The European Medicines Agency advised doctors to continuously monitor patients for six hours after giving them a first dose of Novartis AG's multiple sclerosis drug Gilenya, casting a shadow over the potential blockbuster product.

The move came as the organisation started a review into the safety of the medicine, following reports of heart problems in patients and the death of one person in the United States within 24 hours of starting treatment.

The Swiss ...
Read more : EU says MS drug Gilenya needs heart monitoring | Views : 1486 | Replies : 1


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 : 1555 | 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 : 1792 | 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 : 856 | Replies : 0


 

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