The first oral treatment for multiple sclerosis is now available in the UK following the launch of Novartis' Gilenya on the market, offering patients an important new option against the disease.
Gilenya (fingolimod) has been approved by regulators to treat highly active relapsing remitting multiple sclerosis (RRMS) in patients unresponsive to an interferon injection, or for those with rapidly evolving severe disease.
It is hoped that the drug will help fill a previously unmet need for patients who have failed to respond to injections but are still not eligible for infusion therapy under National Institute for Health and Clinical Excellence guidelines, as until now this group was left with very limited options.
Gilenya's approval was based on the findings of a large clinical trial programme demonstrating its potential in managing MS.
Data from the TRANSFORMS trial showed that the drug cut the annualised relapse rate by 52% compared to an interferon, a result that was echoed in the FREEDOMS study, which also showed that Gilenya reduced disability progression by 30%.
According to consultant neurologist Eli Silber, Gilenya has the potential to be "one of the most significant advances since the first line therapies arrived over a decade ago", being not only the first oral treatment on the market but also providing a new option for those patients with more active disease.
“An oral treatment that cuts relapse rates by half is good news because for patients living with the uncertainty of MS, one relapse is one relapse too many,” he noted.
Aside from the potential benefit to patients eligible for treatment with Gilenya, Novartis is keen to point out the potential cost savings to the National Health Service, which shells out around £3,034 for each MS relapse that requires hospitalisation.
But all eyes will now be on NICE, which is currently assessing the cost-effectiveness of Gilenya to determine whether the drug represents value for money for the NHS, with draft guidance expected in July.