Oral MS drug Gilenya launched in the UK
pharmafile | April 19, 2011 | News story | Sales and Marketing | Novartis, gilenya, multiple sclerosis
Gilenya has become the first oral multiple sclerosis drug to be launched in the UK.
Gilenya (fingolimod) is licenced to treat highly active relapsing remitting multiple sclerosis after beta interferon injections have failed, but for patients whose disease is not severe enough for infusion therapy.
Novartis told Pharmafocus the drug would cost £19,665 for an average patient, per year, including a one off observation cost of £502 for patients receiving their first dose – which makes it cheaper than Biogen’s infusion therapy Tysabri (natalizumab).
Dr Eli Silber, consultant neurologist, said: “This has the potential to be one of the most significant advances since the first line therapies arrived over a decade ago.
“[Gilenya] is not just the first oral treatment, which is an innovation in itself, but provides a new option for people with more active disease.”
The drug has continually impressed in clinical trials, with one key study showing Gilenya cut relapses of MS by 52% at one year compared with interferon beta-1a IM.
Silber added: “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.”
But it does have a number of common, potentially serious side effects, including reduced white blood cells, irregular heart rhythm and gastroenteritis, and because of this Novartis will be required to implement a pharmacovigilance plan for Gilenya.
The drug’s next milestone in the UK will be its appraisal by cost-effectiveness body NICE, which is scheduled to begin on 6 July and produce final guidance by the end of the year.
Ben Adams
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