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Multiple sclerosis treatment Zinbryta was withdrawn in March and now a review by the European Medicines Agency has found its risks outweigh its benefits.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zinbrytaIn March, when I reported that the drug had been withdrawn, I questioned the due diligence of the approval process.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 drug Ocrevus could be barred from health service

Ocrevus may have taken the worldwide multiple sclerosis community by storm but it seems set for a rocky ride in the United Kingdom. It’s quite possible that it will not be available through the country’s National Health Service (NHS).

ocrelizumabAlthough the drug1, known by the non-brand name, ocrelizumab, was licensed by the European Medicines Agency (EMA) in January as an MS treatment, that is not the end of the story. It was licensed to treat both people with relapsing and early primary progressive MS.

However, before a treatment is allowed to be available through the NHS in England and Wales2, it has to be evaluated by the National Institute for Health and Care Excellence (NICE). Disappointingly, it has provisionally decided NOT to recommend ocrelizumab for people with relapsing MS on the NHS.

Fortunately, this is not its final decision. You can let them know what you think through the NICE website before Wednesday April 25, so there is no time to lose. NICE is due to reach its final decision in May.

Should we blame pharmaceutical company Roche for the mess? Well, maybe. NICE has said the evidence submitted by Roche is not enough to show it’s more clinically and cost effective than other treatment options for relapsing MS.

Turn decision around

MS Society director of external affairs Genevieve Edwards said: “Naturally we’re very disappointed by the NICE guidance. But the decision isn’t set in stone, and we’ll be speaking to NICE and the drug manufacturers to make sure we get the right outcome for everyone living with MS.

“Over 100,000 people have MS in the UK, and we’re working hard to make sure they can all access more and better treatments. We’ve been here before and turned it around.”

The review of ocrelizumab as a treatment for primary progressive MS is taking place separately and is not affected by any decision regarding the relapsing form of the disease.

Edwards said: “For us and thousands of others, ocrelizumab also offers immense hope in progressive MS. We’re yet to know what NICE recommends here, and will be continuing our efforts to make sure everyone who could benefit can access the drug. There are still people with MS who don’t have any options for treatment, and addressing this is our absolute priority.”

Anyone who is already receiving Ocrevus through the NHS, should not panic. NICE said its recommendation is not intended to affect treatment that was started before this guidance was published.

“People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop,” it said.

Notes:

1 Ocrelizumab is an intravenous infusion taken every six months. It was licensed to treat both people with relapsing and early primary progressive MS by the European Medicines Agency (EMA) in January this year.

2 The Department of Health in Northern Ireland is expected to make a decision on ocrelizumab for relapsing MS soon. Its decisions are usually based on those made by NICE. The Scottish Medicines Consortium (SMC) is currently carrying out a separate appraisal for people in Scotland.

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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 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.

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.

* * * * *

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.

Zinbryta use restricted in Europe after a death and four serious liver injuries

The European Medicines Agency (EMA) has restricted the use of multiple sclerosis drug Zinbryta. The agency took action after a patient died from liver injury (fulminant liver failure). The patient was in an ongoing observational study. Four cases of serious liver injury have also been reported.

We are all likely to experience some side effect of any medication we take, whether for multiple sclerosis or some other disease. Most of us, hopefully, will only have minor problems, if any, but some will be badly affected.

All medicine manufacturers provide a list of their drugs’ side effects, from major to minor, from common to rare. Pharmaceutical companies provide this information for the benefit of patients, not just healthcare professionals.

And, we need to take those lists seriously. After all, it is our health that is on the line.

I always pay close attention to news of new drugs approved for use in the treatment of MS. But, no matter how good the claimed benefits appear, I focus on the possible side effects admitted by the manufacturer.

Now, that is not to say that all disease modifying therapies (DMTs) are bad for us. But we need to balance benefits against the disadvantaged of possible side effects. Everyone must make their own decision.

Such decisions are personal. I have never accepted any DMT.

Zinbryta – liver damage risk known when approved

zinbrytaZinbryta (daclizumab) is one such DMT and its side effects include the risk of liver damage. The EU knew this when it approved the drug in July 2016. In fact, it put several measures in place to manage this risk. These included the requirement to monitor liver function and provide educational materials to healthcare professionals and patients on the risk of liver damage.

Now, though, a year later, the EMA has provisionally restricted the use of the medicine to:

  • patients with highly active relapsing remitting MS (RRMS) that has failed to respond to certain other treatment, and 
  • patients with rapidly evolving relapsing MS who cannot be treated with other medicines.

In addition, doctors must not give the medicine must to patients with liver injury.

It is not recommended for patients with autoimmune conditions other than MS. Medical professionals should be cautious when the give Zinbryta together with medicines that can damage the liver. Doctors are advised to monitor the liver function of patients to whom they give the medicine. They should closely watch patients for signs and symptoms of liver injury.

The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has issued these provisional recommendations as a precaution and to ensure that Zinbryta continues to be used as safely as possible while a review of its liver safety is ongoing.

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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 Features Writer with Medical News Today. 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.

 

European Medicines Agency recommends licence for cladribine (Mavenclad)

cladribine

The European Medicines Agency has approved cladribine (brand name Mavenclad) for use with multiple sclerosis.

The agency has recommended that a licence should be granted, by the European Commission, for the treatment of highly-active relapsing MS. Cladribine is currently an anti-cancer drug under the brand names Leustat and Litak.

The next step in the process is for the European Commission to grant a licence.

As far as the UK is concerned, Cladribine will also have to be appraised by National Institute for Health and Care Excellence (NICE) and the Scottish Medicines Consortium (SMC). These organisations decide whether the drug will be available through the National Health Service.

NICE has already started the appraisal process in anticipation of a European licence being granted. NICE could publish its decision in February 2018. If NICE approves the use of cladribine, it could be available on the NHS as early as June next year.

The medication’s development has met mixed fortunes. Russia and Australia both approved it as an MS treatment in 2010 but Europe and the United States turned it down because of safety concerns.

In 2011, a licence application was refused because of concerns about a higher risk of cancer in people taking cladribine. However, in July last year, Merck announced that further research had found that there is no such increased risk and that the EMA had accepted a new licence application.

How to take cladribine

Patients take cladribine as a pill in two treatment courses:

  • In the first course, a patient takes cladribine pills for five consecutive days in the first month and for five consecutive days in the second month
  • The second course is taken 12 months later. Again a patient takes cladribine pills for five consecutive days in the first month and for five consecutive days in the second month

Cladribine was found to reduce the risk of relapses by 58%, compared to placebo, in large clinical trials. Also, it reduces the risk of increased disability.

Clinical trials reported main side effects include reduced white blood cell counts, which in most cases was mild or moderate, and infections including herpes zoster (shingles).

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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 Features Writer with Medical News Today. 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.