London and Milan
April 3, 2021
By Christian Plumb, Economics Correspondent
Biogen’s Alzheimer’s drug is unlikely to win European approval.
Biogen’s plan to get its new Alzheimer’s drug on the market in Europe has been dealt a blow by the drug’s failure in a large clinical trial.
The failure was disclosed in Biogen’s 2017 Annual Report.
Scientists and Alzheimer’s patients alike are hoping Biogen’s new drug, aducanumab, will help bring a controlled but slow spread of the disease.
Alzheimer’s affects more than five million people across Europe.
Biogen’s shares closed at $342 each, before the revelation of the clinical trial failure.
The company said no one would know for years the exact cause of the new drug’s failure.
This is the first Alzheimer’s drug that hits a specific area of the brain, in a big way, and so even when you guess the cause of a disease, it could be years before the mystery is solved.
Biogen’s chief financial officer said it would be at least a decade before the company knows what the substance is that caused the failure.
However in 2015, Prof Paolo Paoletti from King’s College London looked at other medicines that had failed the same hurdle as aducanumab.
He made a statistical error in the study data by not taking into account a number of fatal lung infections experienced by patients in the trial.
This error lowered the primary endpoint, meaning the results failed to meet the minimum requirement for success.
Biogen maintains aducanumab performed well in the trial, although deaths due to the lung infections were still reported in patient records.
The company will continue to invest heavily in the drug in spite of the clinical setback.
Biogen’s problems stem not only from the nasty lung infections that have so far brought down other so-called hot drugs, but also from the fact the drug does not work as well in older patients as it does in younger ones.
Professor Paoletti said they knew the drug would have to address an older age population, and if Biogen can’t do this, it is unlikely to be successful.
In June this year, Biogen will reveal results of another key clinical trial. It is targeting patients at risk of dementia.
This part of the trial is looking at the drug in patients with early dementia.
In a later stage of the trial it will also be investigating the impact of aducanumab in patients who were already in severe dementia.
The Biogen Alzheimer’s drug will continue to receive investment from the company in 2017, and Biogen will make further progress in this clinical trial.
A Biogen spokeswoman also said the company’s collaboration with Eisai, its partner in developing the new drug, continued to be a good match.
Biogen will now seek to get European approval for the drug on compassionate grounds.