After the rejection by the EMA, the pharmaceutical company submitted an application for review. However, it is now withdrawing the application for market approval.
(Photo: Reuters)
Bangalore The US pharmaceutical company Biogen has withdrawn its application for market approval for its Alzheimer’s drug Aduhelm in Europe due to the lack of prospects of success. This means that the controversial drug with the active ingredient aducanumab will no longer have a chance of being launched on the European market for the time being. To do this, Biogen would probably have to present data from a new study, which in turn would take years.
The European Medicines Agency (EMA) pointed out in discussions that it did not consider the data submitted to be sufficient to support approval, the US pharmaceutical company said on Friday afternoon.
The EMA had already rejected the drug once in December, after which Biogen requested a review of the assessment. Biogen’s interim chief research officer, Priya Singhal, said the company remains committed to the safety and efficacy of aducanumab and is optimistic about the forthcoming data analysis to continue to provide important scientific insights into this new class of drugs.
In any case, most investors had no longer given a high chance of approval in Europe. Still, Biogen stock fell more than 3 percent on Friday afternoon in response to the decision.
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Many experts, including the EMA’s Committee for Medicinal Products for Human Use (CHMP), which is responsible for the assessment of medicinal products, believe that there is insufficient evidence that Aduhelm can actually delay or stop the progression of Alzheimer’s disease.
Focus on Roche and Eli Lilly
The hope of billions in sales was once associated with the drug. The drug has been approved in the USA since June 2021. But in view of the doubts about the mechanism of action, the approval there was strongly criticized by many experts. So far, sales have fallen far short of original expectations.
Despite this, some physicians and patient associations had spoken out in favor of conditional approval of the drug under strict conditions. The background is the still unmet need for therapies against dementia. So far there are no active ingredients that attack the cause of Alzheimer’s disease.
The focus will now be even more on product candidates from the pharmaceutical companies Roche and Eli Lilly, which are testing active ingredients for Alzheimer’s disease in advanced studies. However, these follow the same controversial principle of action as the Biogen drug.
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