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Novartis works in multiple sclerosis (MS) switch

By: Pharma News | Views: 1029 | Date: 22-Jul-2013

Novartis’ oral MS drug Gilenya has been found to help multiple sclerosis (MS) patients who switch to it after taking standard interferon (interferon beta-1a), according to new analyses of a Phase III trial.Data from the TRANSFORMS study presented at the European Neurological Society in Barcelona suggests using Gilenya (fingolimod) in this way increased the proportion of disease-free patients from 44.3% to 66% after one year.

Novartis works in multiple sclerosis (MS) switch 


Novartis’ oral MS drug Gilenya has been found to help multiple sclerosis (MS) patients who switch to it after taking standard interferon (interferon beta-1a), according to new analyses of a Phase III trial.

Data from the TRANSFORMS study presented at the European Neurological Society in Barcelona suggests using Gilenya (fingolimod) in this way increased the proportion of disease-free patients from 44.3% to 66% after one year.

The key measure was the link between disease activity - relapses, three-month disability progression or MRI activity - in the first year of therapy and long-term clinical outcomes.

Those who experienced disease activity before entering the study - even though they had received disease-modifying treatment - had a lower annualised relapse rate (ARR) on Gilenya compared to those given interferon for the first year (ARR 0.19-0.22 versus 0.31-0.32).

If treatment was changed from interferon to Gilenya after one year, ARR was reduced by more than 50% from between 0.33-0.37 ARR to 0.14-0.16 ARR and remained low to the end of the 4.5 year extension study.

Brain volume loss - an area where Gilenya has already scored highly in studies - was reduced by about 50% after one year in patients taking Gilenya compared to those taking interferon.

MS is a chronic disease that attacks the central nervous system and is estimated to affect 2.5 million people worldwide - many of them under the age of 40.

“Data have consistently shown that treatment with Gilenya leads to more patients staying disease-free, compared to standard interferon treatment,” said Timothy Wright, global head development, Novartis Pharmaceuticals.

“MS is a chronic neuroinflammatory and neurodegenerative illness where disease activity leads to accumulation of disability and loss of brain tissue. These new findings demonstrate the effect of Gilenya on these key disease measures, both in the early years and in the longer-term,” he concluded.

While the causes of MS are not completely clear, it is thought that Gilenya works by preventing the cells that cause inflammation in the CNS from leaving the lymphoid tissues.

This reduces their potential for damage, while Gilenya also acts on the neurodegeneration process in the brain and spinal cord. While its performance is seen as impressive, Novartis does not have the field to itself.

Earlier this year the CHMP recommended approval for a couple of Gilenya’s potential rivals in Europe, Biogen Idec’s Tecfidera (dimethyl fumarate) and Genzyme’s Aubagio (teriflunomide), both of which are once-daily oral treatments for adults with relapsing-remitting MS.

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