Biogen is planning to ship its newly approved Alzheimer’s treatment Aduhelm in approximately two weeks, chief executive officer (CEO) Michel Vounatsos said in an investor call this week.
The company has over 900 sites ready to start administering Aduhelm (aducanumab) to patients. The sites include clinical trial centres, where the treatment will be given to patients who have been tested for amyloids, as well as additional sites that have the appropriate equipment to test and treat Alzheimer’s disease patients.
Earlier this week, the US Food and Drug Administration (FDA) approved Aduhelm for the treatment of Alzheimer’s disease following months of controversy surrounding the drug.
Although previous FDA briefing documents backed aducanumab – which now has the new brand name Aduhelm – the regulatory agency’s Peripheral and Central Nervous System Drugs Advisory Committee overwhelmingly voted no on a number of counts regarding the drug in November 2020.
Now, two members of the advisory panel have resigned after expressing disappointment about how the FDA handled recommendations made by advisors.
This included David Knopman, a neurologist at the Mayo clinic and investigator involved in clinical trials of Aduhelm who was recused from voting in the November meeting.
Knopman told Reuters: “I was very disappointed at how the advisory committee input was treated by the FDA. I don’t wish to be put in a position like this again.”
Joel Perlmutter, another advisory panel member and neurologist at Washington University, has also resigned. Perlmutter, who voted against approval of Aduhelm, attributed his resignation to the FDA’s failure to discuss the drug further with advisors prior to approval.
Biogen’s drug is the first treatment approved by the FDA that targets the underlying causes of Alzheimer’s disease, by breaking down amyloid plaque build-up in the brain.
Although Aduhelm has only been tested in patients with early-stage Alzheimer’s disease, the FDA approved the drug for all Alzheimer’s patients – reflecting a patient population of approximately six million people in the US.