Zinbryta risks outweigh benefits, European report

Multiple sclerosis treatment Zinbryta was withdrawn in March and now a review by the European Medicines Agency has found its risks outweigh its benefits.

The review confirms the drug’s association with the risk of developing severe and potentially fatal immune reactions in the brain, liver and other organs. It was carried out by to the European Medicines Agency‘s (EMA)’s Pharmacovigilance Risk Assessment Committee (PRAC).

zinbrytaIn March, when I reported that the drug had been withdrawn, I questioned the due diligence of the approval process.

EMA says that 12 cases of inflammatory brain disorders worldwide were potentially related to the medication’s use. Further, encephalitis and meningoencephalitis, or inflammation of the membranes enveloping the brain and spinal cord, resulted in three deaths.

Zinbryta is no longer available through European pharmacies and hospitals but the EMA recommends healthcare professionals to monitor patients who were treated with Zinbryta.

The EMA says: “Patients could be at risk from the start of treatment and for several months after stopping treatment, and it is not possible to predict which patients will be affected. The PRAC therefore confirmed its previous conclusions that risks of Zinbryta outweigh its benefits for patients with multiple sclerosis.”

Biogen and Abbie are working closely with the US Food and Drug Administration (FDA) for the withdrawal of Zinbryta in the US, according to Zinbryta’s website.

Anyone who takes Zinbryta is advised to contact their healthcare professionals and discuss a new treatment strategy.

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Affiliate disclaimer: This affiliate disclosure details the affiliate relationships of MS, Health & Disability at 50shadesofsun.com with other companies and products. Read more.

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50shadesofsun.com is the personal website of Ian Franks, a freelance medical writer and editor for various health information sites. He enjoyed a successful career as a journalist, from reporter to editor in the print media. He gained a Journalist of the Year award in his native UK. Ian received a diagnosis of MS in 2002 and now lives in the south of Spain. He uses a wheelchair and advocates on mobility and accessibility issues.

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Note: Health-related information available on 50shadesofsun website is for your general knowledge only. It is not a substitute for medical advice or treatment for specific medical conditions. I am not a doctor, so cannot and do not give you medical advice. You should seek prompt medical care for any specific health issues. Also, consult a doctor before starting a new diet or exercise programme. Any opinions expressed are purely my own unless otherwise stated.

MS treatment Zinbryta (daclizumab) withdrawn worldwide amid safety concerns

Disease modifying therapy daclizumab (Zinbryta) has been withdrawn from sale worldwide. Its manufacturers took the decision after reports that a number of people taking the treatment developed serious inflammatory brain disorders. That’s how the news was announced on the MS Society’s website.

In the UK, the treatment will no longer be available via the country’s National Health Service (NHS).

zinbryta withdrawnTo me, though, the drug’s withdrawal after safety concerns raises an important question. Just how good are our procedures for approving and licensing new drugs? Despite supposedly stringent procedures, including clinical trials, this drug was given the green light. But, so soon after approval, serious side effects have been reported.

This must surely mean that the approval process was not sufficiently strict. Maybe, the pressure on the need for approval somehow managed to overcome the necessity of due diligence.

zinbrytaSo, what has happened? Manufacturers Abbvie and Biogen have withdrawn daclizumab from the market. This was because of a number of cases of serious brain inflammation) (encephalitis and meningoencephalitis). Already, the European Medicines Agency (EMA) has started an urgent review of the drug and these cases.

A statement on Biogen’s website says: “Patient safety is the top priority for Biogen and AbbVie.

“Given the nature and complexity of adverse events being reported, characterizing the evolving benefit/risk profile of Zinbryta will not be possible going forward given the limited number of patients being treated. Therefore, Biogen and AbbVie believe it is in the best interest of patients to voluntarily withdraw worldwide marketing authorizations for Zinbryta.

Having Zinbryta injections? What to do now

“Biogen will continue to work collaboratively with regulatory authorities and with healthcare providers in their management of Zinbryta patients.”

As part of the withdrawal, all clinical trials involving the treatment will also be stopped. People in those clinical studies who have any question should contact the doctor treating them in their study.

The EMA advises that:

  • • anyone currently taking Zinbryta should not stop without first talking to their neurologist or MS nurse
  • doctors should review anyone currently taking Zinbryta and discuss switching to an alternative treatment as soon as possible. (The National MS Society in the US says that safety monitoring should be continued, adding “According to the medication guide, this would include monthly blood tests to monitor liver function for up to six months after the last dose.”)
  • no one should begin taking Zinbryta

Zinbryta was approved in 2016 for use as a disease modifying therapy (DMT) for people with relapsing remitting MS. However, that approval was only for anyone who continued to have relapses despite having tried at least two other DMTs.

One good thing about the decision to withdraw Zinbryta is that the manufacturers took action themselves and did not wait for regulators to act.

For anyone living in the UK, the MS Society says: “If you’re concerned by this news, you can call our MS Helpline on 0808 800 8000 (Monday to Friday 9am-7pm) or email helpline@mssociety.org.uk for information and support.”

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Affiliate disclaimer: This affiliate disclosure details the affiliate relationships of MS, Health & Disability at 50shadesofsun.com with other companies and products. Read more.

* * * * *

50shadesofsun.com is the personal website of Ian Franks, a freelance medical writer and editor for various health information sites. He enjoyed a successful career as a journalist, from reporter to editor in the print media. He gained a Journalist of the Year award in his native UK. Ian received a diagnosis of MS in 2002 and now lives in the south of Spain. He uses a wheelchair and advocates on mobility and accessibility issues.

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Note: Health-related information available on 50shadesofsun website is for your general knowledge only. It is not a substitute for medical advice or treatment for specific medical conditions. I am not a doctor and cannot and do not give you medical advice. You should seek prompt medical care for any specific health issues. Also, consult a doctor before starting a new diet or exercise programme. Any opinions expressed are purely my own unless otherwise stated.

After Long Wait, Zinbryta Gains Approval in Areas of the UK

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News that daclizumab, brand name Zinbryta, has been given the go-ahead to be available through the U.K.’s National Health Service (NHS) for treating relapsing MS, at least in part of the country, is good news. But why has the decision taken so long?

Possibly, because the first decision, last September, was ‘no.’

The latest decision by the National Institute for Health and Care Excellence (NICE) covers only England and Wales. Hopefully, similar announcements will be made for people in Scotland and Northern Ireland in coming months.

The decision means the NHS will have a legal obligation to provide the treatment to people with relapsing MS, whose health care professional prescribes it to them.

But there are conditions.

Patients must have either:

  • “Active” relapsing MS that’s been treated with another disease-modifying treatment, or;
  • “Rapidly evolving severe” MS (defined by at least two relapses in the previous year and an MRI scan showing new lesions)

And it will be available only to people who are unable or unwilling to take alemtuzumab.

Interestingly, the U.S. Food and Drug Administration (FDA) approved Zinbryta early last year and the European Medical Agency (EMA) followed suit in June, but it has taken another nine months for NICE to make up its mind. I find such a delay completely unacceptable.

Isn’t it time that countries around the world got together and presented a united front on new medications being brought out for the use of those of us who need them? Shouldn’t we consider such new treatments and give necessary approvals globally, not on a piecemeal basis, as we do now?

Of course, such revolutionary thinking is never likely to be taken seriously, as it would mean the dismantling of national organizations such as the FDA. Well, why not? On the other side of the Atlantic, there is one body that does the job for nearly 30 countries — the EMA.

If one organization can cover all Europe, why can’t an international one cover the whole world? Reducing the number of approval bodies should cut costs, too.

But it would need its decisions to include that medical insurance companies would have to pay for it to be provided to patients, and for it to be available through the NHS, without further consideration.

Could it work? Of course! Everything is possible. Will it ever happen? Not a chance

This article, written by me, was first published by Multiple Sclerosis News Today.

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[You are invited to visit my personal MS, Health & Disability website at 50shadesofsun.com].

50shadesofsun.com is the personal website of Ian Franks, who is Managing Editor (columns division) of BioNews Services. BioNews is owner of 50 disease/disorder-specific news and information websites – including MS News Today. Ian has enjoyed a successful career as a journalist, from reporter to editor, in the print media. During that career he gained a Journalist of the Year award in his native UK. He was diagnosed with MS in 2002 but continued working until mobility problems forced him to retire early in late 2006. He now lives in the south of Spain. Besides MS, Ian is also able to write about both epilepsy and cardiovascular matters from a patient’s perspective and is a keen advocate on mobility and accessibility issues.

Just two weeks to fight for MS treatment

Anyone wishing to take issue with the draft recommendation to not make daclizumab1 (Zinbryta) be made available as a treatment on the NHS in England and Wales has just 15 days to do so. Comments must be received by Friday October 21.

So, if you want a change of heart, don’t delay. The time to stand up for MS patients is now!

The UK’s National Institute for Health and Care Excellence (NICE) is responsible for evaluating new drugs and treatments, along with their costs. It then makes recommendations as to whether or not they should be available through the country’s National Health Service (NHS) in England and Wales. Other parts of the UK have their own guidance bodies.

daclizumabIn a document published on the NICE website, the appraisal committee’s preliminary recommendation states: “Daclizumab is not recommended within its marketing authorisation for treating relapsing forms of multiple sclerosis in adults.”

The committee was critical of the analysis submitted by the manufacturer of the cost effectiveness of daclizumab, compared with other disease modifying treatments.

The NICE appraisal committee is scheduled to have another meeting on November 2. It is expected to review the comments received together with further evidence from the manufacturer.

NICE is expected to publish its final guidance next year.

1 Daclizumab is an experimental drug treatment being developed for relapsing MS. It is taken as an injection under the skin, once a month. In clinical trials, daclizumab reduced relapse rates by approximately 50% compared to placebo and by 45% compared to beta interferon. The drug was licensed in Europe in July 2016.

Serious infections, serious skin reactions and impaired liver function occurred more frequently in people treated with daclizumab than in other treatment groups.

 

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New MS drug approved in USA and Europe

euro agencyA new disease modifying treatment is being considered for use in the UK following it being approved in the USA and Europe.

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.”

 

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