AMSTERDAM: The European Union’s drug regulator on Friday rejected Biogen Inc’s controversial Alzheimer’s drug, Aduhelm, dealing a blow to the US drug maker after a panel voted against the treatment last month.
The drug, the first new treatment for the memory-robbing disease in nearly 20 years, has been battling slow uptake since its approval in the United States in June as experts have questioned the rationale for green lighting it without more definitive proof of benefit.
Aduhelm works by removing sticky deposits of a protein called amyloid beta from the brains of patients in earlier stages of Alzheimer’s in order to stave off its ravages.
The European Medicines Agency noted that although Aduhelm reduced amyloid beta in studies, the link between this effect and clinical improvement in the disease had not been established.
The Cambridge, Massachusetts-based company’s shares fell 4.2% in premarket trading on the news. Biogen said in a statement it would seek a re-examination of the agency’s opinion.
The results from the main studies of the drug were conflicting and did not show that Aduhelm was effective in treating adults with early stage Alzheimer’s, the EMA said.