New MS drug approved in USA and Europe
ON JUNE 20, 2016
Already approved by America’s Food and Drug Administration (FDA), daclizumab, known as Zinbryta, has now been given the nod by the European Medicines Agency (EMA). The agency has recommended that the drug be licensed to treat people with relapsing forms of MS.
The UK’s National Institute for Health and Care Excellence (NICE) is now going to conduct an appraisal before deciding whether or not to make this treatment available on the NHS in England and Wales.
Daclizumab is injected once a month and works by reducing the number of immune cells thought to contribute to myelin damage seen in MS. However, like all medicines, it does have the risk of side effects, some extremely rare, and not everybody gets them. Side effects include fatigue, stomach upset, infections, and impaired liver function. Serious but rare effects include what are referred to by manufacturer Biogen as ‘fatal events’.
Indeed, the prescribing information includes a boxed warning about the potential for severe liver injury, including life-threatening and fatal events. For “fatal events,” read “death.”
It also highlights other important risks of Zinbryta treatment, including inflammation of the colon (non-infectious colitis), skin reactions, and enlargement of lymph nodes (lymphadenopathy). Additional warnings include hypersensitivity reactions (anaphylaxis or angioedema), increased risk of infections, and symptoms of depression and/or suicidal thoughts. As if people with MS are not depressed already!
According to data from a phase 3 trial involving 1,841 people with relapsing remitting MS has indicated daclizumab to be more effective than beta-interferons in reducing relapses. The trial showed after 96 weeks, 73% of participants taking daclizumab were relapse-free, compared to 59% of participants taking beta-interferon.
Britain’s MS Society is planning to submit evidence to NICE as part of its Treat Me Right campaign that is calling for all licensed MS treatments to be available on the NHS to everyone eligible for them.
Treat Me Right
The MS Society is fighting for the right treatment at the right time for people with MS, whatever their situation, wherever they live.
It believes that people with MS should have fair and equal access to treatments wherever they live. But, at the moment, this isn’t happening. The aim of the campaign is to change that.
The society says: “We’re campaigning to make these goals a reality:
- All licensed MS treatments available on the NHS to everyone eligible for them
- Regular reviews of treatment and care by MS specialists for everyone with MS
- Accessible information about treatment options, and support to be equal partners in decision-making, available to all people with MS
“We hope they’ll help people with MS get the right treatment at the right time.”