MS drug Gilenya prescriptions slowing due to lack of monitoring facilities




Novartis’ multiple sclerosis (MS) pill Gilenya faces slowing prescriptions in New York because of a lack of facilities to perform first-dose observations, neurologists told Biopharm Insight. However, Novartis has been in contact with a number of clinicians and is working on increasing the number of sites.

A US Food and Drug Administration (FDA) review was initiated after a patient died within 24 hours ...

The multiple sclerosis medication fingolimod (Gilenya) led to "rapid and sustained" reductions in MRI-documented inflammatory lesion activity, researchers reported.

In a two-year randomized trial, the medication also slowed the rate of brain volume loss compared with placebo, according to Ernst-Wilhelm Radue, MD, of University Hospital Basel in Basel, Switzerland, and colleagues.

Changes in lesion volume over time also favoured the medication rather than placebo, Radue and colleagues reported online in Archives of Neurology.

Combined ...

Gilenya® shows long-term efficacy and safety in extension of phase III head-to-head study



New long-term data for Gilenya® (fingolimod), the only oral therapy approved to treat people with relapsing forms of multiple sclerosis (MS), show a sustained efficacy benefit and a consistent safety profile with up to 4.5 years of continuous treatment. These results, from an extension of the phase III head-to-head TRANSFORMS study, also showed improved efficacy for patients switched to Gilenya from ...

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 ...

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

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) ...

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 ...

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 ...

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



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 ...

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 ...