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 ...

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 ...

Relapse and disability outcomes in patients with MS treated with fingolimod



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 ...

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 ...

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 ...

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 ...

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 ...

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 ...

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 ...