Biogen has issued a staunch defence of the science and approval process behind its controversial Alzheimer’s drug, saying that “misinformation” is fuelling criticism of the treatment.
The pharmaceutical company has faced mounting scrutiny following the approval of its Alzheimer’s drug last month by the US Food and Drug Administration.
Michel Vounatsos, chief executive of Biogen, said in an earnings call on Thursday: “I want to be clear that Biogen stands behind the integrity of the review process.”
The treatment, which is sold under the brand name Aduhelm, “was approved appropriately on very solid grounds and represented the right thing to do”, he said.
Some scientists have said the treatment does not work and should never have been given the go-ahead, while others allege that the US medicines regulator and the drugmaker had collaborated too closely in the run-up to the approval.
The $56,000-a-year infusion treatment is the first Alzheimer’s drug to be given the green light in nearly two decades. Biogen claims the drug is the first to treat the causes of the debilitating disease, rather than just helping patients manage their symptoms.
Earlier this month the acting head of the FDA took the unusual step of calling for an independent investigation into the agency’s interactions with Biogen executives as questions mount over why the drug was approved.
Michael McDonnell, Biogen’s chief financial officer, said the Massachusetts-based drugmaker welcomed the formal review and that it would be “good for everyone involved to ensure confidence in the therapy”.
Biogen said revenues from Aduhelm hit $2m in the second quarter, but Vounatsos noted that a “big chunk” of the sales were inventory and did not reveal the number of patients who have started treatment.
McDonnell defended the drug against several claims that he called “factually incorrect”, including that reducing amyloid plaques in the brain does not result in slowing the progress of Alzheimer’s disease.
Aduhelm is designed around the amyloid hypothesis, whose proponents say that clumps of protein building up in the brain cause Alzheimer’s.
Numerous pharmaceutical companies have previously tried and failed to develop amyloid-clearing drugs and prove that removing the proteins can mitigate the disease.
“There is no basis for using the failure of these antibodies as a reason not to approve [Aduhelm],” said McDonnell, who said there was no evidence that those other treatments actually removed amyloids.
He also said claims that the company carried out post hoc analysis were factually incorrect. Biogen’s clinical trials were initially halted in March 2019 after an independent committee found that the drug was not going to be effective. The company later presented new analysis saying the treatment was successful when taken at a higher dose.
McDonnell said people who believed approval of the drug would lead to less investment into research for other Alzheimer’s treatments were “contradicted by precedent”, citing the history of research into HIV and multiple sclerosis.
Biogen’s second-quarter sales fell 25 per cent compared with the same period last year, to $2.8bn. Analysts had expected earnings of $2.6bn, according to FactSet.
Shares in Biogen rose 1.4 per cent in morning trading on Thursday in New York.