Disease modifying therapy daclizumab (Zinbryta) has been withdrawn from sale worldwide.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).
To 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.
So, 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 Manufacturers Abbvie and Biogen have withdrawn daclizumab from the market.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 firstname.lastname@example.org for information and support.”
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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.