(Reuters) – The European Medicines Agency (EMA) on Friday refused to approve Biogen’s drug for Alzheimer’s disease, Aduhelm, a further setback for the American manufacturer which is struggling to market its treatment.
The drug – the first new treatment for the disease in twenty years – was approved in the United States last June, a controversial decision due to still incomplete results on the benefits of the treatment.
Aduhelm works by destroying the amyloid plaques that build up in the brain, between neurons, a phenomenon that could be the cause of the cognitive losses associated with the disease.
The AEM noted that although studies of the drug have shown a reduction in beta-amyloid protein deposition thanks to Aduhelm, the link between this effect and clinical improvement in the disease has not been established.
Biogen has said it will seek a reconsideration of this opinion.
Shares of the Cambridge, Massachusetts-based company fell 4.2% in pre-market trading on Wall Street.
Biogen had bet on Aduhelm’s sales to cushion the impact of growing competition on its main revenue streams but so far the lab has been working to convince hospitals and clinics to use the treatment of worth $ 56,000 (nearly 50,000 euros) per year, and insurers will reimburse it.
In Biogen’s latest quarterly results, Aduhelm’s turnover reached just $ 300,000, while analysts had forecast an average of $ 10.8 million.
(Pushkala Aripaka and Mrinalika Roy report in Bangalore; French version Dina Kartit, edited by Jean-Stéphane Brosse)
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