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Multiple sclerosis: a drug that should never have been authorised

In March 2018, after several deaths, daclizumab (Zinbryta°) was withdrawn from the market. The European Medicines Agency should never have authorised this drug.

In patients with multiple sclerosis, interferon beta is the first-choice treatment, for want of a better option. Despite the severity of multiple sclerosis in some patients, there is no justification for exposing them to drugs such as alemtuzumab, natalizumab or teriflunomide, whose harm-benefit balance is undeniably unfavourable.

Daclizumab (Zinbryta°), an immunosuppressant, was approved in Europe in 2016 in adult patients with multiple sclerosis. The drug was not marketed in France.

The harm-benefit balance of daclizumab in multiple sclerosis appeared unfavourable from the initial evaluation stage: the two main clinical trials revealed numerous serious, even fatal adverse reactions, liver damage in particular, as well as its very limited efficacy. During the review of the clinical evaluation in 2016, the European Medicines Agency was lax, recommending the granting of a marketing authorisation regardless of the line of treatment and ignoring the serious adverse effects observed.

It took an accumulation of reports of fatal liver damage and  then fatal brain damage before the European Commission finally withdrew the marketing authorisation for daclizumab in March 2018.

Daclizumab in multiple sclerosis is a further example that illustrates the medicines agencies’ tendency to put the financial interests of the pharmaceutical companies before patient safety. It was especially important to deny authorisation in view of the harms already known prior to the marketing authorisation.

©Prescrire 1 July 2018

"Daclizumab (Zinbryta°) and multiple sclerosis after multiple treatment failures" Prescrire Int 2018; 27 (195): 173-175. (Pdf, subscribers only).

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See also:

Multiple sclerosis.
Fampridine, after a second
look: unfavourable
harm-benefit balance
Prescrire Int 2018;
27 (194):163.
Pdf, subscribers only

Alemtuzumab. Multiple
sclerosis: biased evaluation,
evidence of serious risks
Prescrire Int 2018;
24 (158):69.
Pdf, subscribers only

Multiple sclerosis: neither
natalizumab nor alemtuzumab
(March 2015)

Natalizumab (Tysabri°)
and multiple sclerosis
Prescrire Int 2015;
24 (158): 65-67.
Pdf, subscribers only

Teriflunomide. Multiple
sclerosis: just a metabolite
of leflunomide
Prescrire Int 2015;
24 (158) : 61-6.
Pdf, subscribers only