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Biogen and AbbVie pull MS drug Zinbryta from the market

Potential risks of liver damage and immune-related conditions have been reported

Biogen

Biogen and AbbVie have voluntarily withdrawn their multiple sclerosis drug Zinbryta from the market worldwide, saying the move is in the best interests of patients.

Escalating concerns about the safety of Zinbryta (daclizumab) - and particularly cases of liver damage and immune-related conditions - are behind the decision, which was announced on the same day that the EMA started an ‘urgent review’ of Zinbryta.

The EU regulator says there have been eights cases of inflammatory brain disorders in patients taking the antibody, including seven in German and one in Spain, including cases of encephalitis and meningoencephalitis.

In a statement, Biogen said that given the “nature and complexity of adverse events being reported”, as well as the “limited number of patients being treated” with the drug, it was better to withdraw it from the market altogether. It has also decided to discontinue all clinical trials of daclizumab.

Zinbryta was approved for marketing in 2016 but has barely got going as an MS therapy thanks mainly to warnings on the label of liver damage risks. Last November the EMA reported that it had safety concerns about the product that caused it to restrict prescribing to patients who have tried at least two other disease-modifying treatments and cannot be treated with any other MS treatments.

That had a predictable impact on usage, and Biogen reported a little over $50m in sales last year - up from $8m in 2016 - but revealed an 18% decline in the fourth versus the third quarters of the year.

The drug had been launched to date in the EU, US, Switzerland, Canada and Australia and developed a modest following because it is dosed just once a month by self-administered injection, less frequently than interferon beta therapies.

The EMA recommends that doctors should review patients currently treated with Zinbryta “and initiate alternative therapy, as soon as possible”.

Article by
Phil Taylor

5th March 2018

From: Regulatory

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