The US FDA approves the controversial Alzheimer’s drug aducanumab. The biotech company can look forward to billions in sales.
For the first time in 18 years, the US regulatory authority FDA has a drug to treat Alzheimer’s disease given the okay. Biogens aducanumab is said to be able to slow down the progression of the disease slightly.
The FDA Has Approved @Biogens #Aducanumab, The First New #Alzheimers Treatment in 18 Years. This is great news for patients and their caregivers. #MedicalResearch #DrugDevelopment #progress https://t.co/ZqjsHKUhMz
— NeuroScientific Biopharmaceuticals (@NSB_biopharma) June 8, 2021
After the decision, the Biogen share rose at times by 64 percent, at the time of going to press for this issue it was still around 50 percent up. A expected nalysten that Biogen can take to the center in the coming years between seven and 18 billion dollars per year. So far there is no drug that really tackles the roots of the disease – but there are around six million patients in the US alone.
The extent to which the high sales forecasts can actually be achieved cannot yet be foreseen. Payers and doctors could significantly slow down the prescription of aducanumab, which is to be sold under the name Aduhelm. Because the drug is medically extremely controversial. In 2019, Biogen stopped two phase 3 studies with the same structure because the drug showed no effect. A few months later, the company then announced that it had observed an effect at particularly high doses in one of the studies. Such retrospective analyses of subgroups are not considered meaningful in medicine because they are subject to great statistical uncertainties. For this reason, an external advisory committee convened by the FDA voted against approval.
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Usually the authority follows the suggestions of the expert panel. But not this time. The FDA is calling for another study to prove the slowing down of cognitive decline. Otherwise the approval could be withdrawn again. But she apparently gives Biogen up to nine years to do it, in the meantime the group is allowed to cash in. Biogen has manoeuvred itself into an excellent starting position with the surprisingly high price of 56,000 dollars per year and the possibility of treating patients of all stages of Alzheimer’s disease. The US biotech group now has a strong growth driver for the coming years – at least until the competition follows suit.