Biogen Alzheimer's filing likely hit by pandemic, as drugs against the disease set for delay

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It’s a pretty grim story in Alzheimer’s disease research, with years of flops and setbacks against the memory-wasting disease.

There is a small glimmer of hope (a very, very small glimmer) that Biogen’s once-failed, now-resurrected Alzheimer’s effort aducanumab can be the first approved med for the condition in more than 15 years.

Biogen has been hinting since the start of the year, with investors also making the same prediction, that a filing with the FDA was “imminent”; we’re now four months down the line, and a major global pandemic appears to have scuppered those plans.

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A review from life sciences data firm GlobalData said “the filing and review of Biogen’s recombinant human monoclonal antibody (mAb) aducanumab is expected to take more time than was estimated.” How much time, we don’t know.

We do know it will still be one of the most controversial drugs to come across the FDA’s desk, but we’ll have to wait longer to see how the regulator deals with it.

It’s also all too easy to forget just how damaging, life-threatening and life-changing other diseases and disorders outside COVID-19 are; you’re not worried about that darkening mole on your arm when a car is careening toward you at 90 mph.

But other areas are suffering. Whether Biogen’s drug can help Alzheimer's patients or not, GlobalData points out that many trials for the disease are at risk from delay given most patients required to test such meds are being told to self-isolate because most are elderly and considered vulnerable to the risks of COVID-19.

In the U.K., for example, everyone over 70 years old has been told to stay at home for 12 weeks. Virtual trials can help here, but they come with more challenges for an older population not always used to such technology.

“With many countries putting clinical trials studies on hold, pharmaceutical companies are shifting their overall priorities away from some current indications toward COVID-19,” the firm said in a report.

“This could put several Alzheimer’s Disease (AD) drugs, of which there are 38 in phase 1, 19 in phase 3 and 37 in phase 2, at risk of delay.”

Alessio Brunello, senior pharma analyst at GlobalData, said: “Not all pharmaceutical companies have been responding in the same ways to the COVID-19 pandemic. For example, Roche is continuing both enrolment and dosing in the company’s AD late-stage trial of gantenerumab. On the other hand, Eli Lilly, which has several AD drugs in the pipeline, is halting enrolment and postponing new trials while continuing dosing in ongoing trials."

He added: “The disruption of important clinical research by the COVID-19 pandemic is linked to the particular vulnerability of older adults. The number of deaths in the elderly population worldwide has already reached significant numbers and participants of AD trials that died from the virus can significantly affect the outcome of AD studies.”