Biogen has issued a firm defense of the science and approval process behind its controversial Alzheimer’s drug, saying that “misinformation” is intensifying criticism of the treatment.
After the U.S. Food and Drug Administration approved its Alzheimer’s drug last month, the pharmaceutical company is facing increasingly stringent scrutiny.
Biogen CEO Michel Vounatsos said on Thursday’s earnings call: “I want to make it clear that Biogen supports the integrity of the review process.”
He said that this treatment, sold under the Aduhelm brand, “is properly approved on a very solid basis and represents the right approach.”
Some scientists say that this treatment does not work and should not be approved, while others claim that the U.S. drug regulatory agency and drug manufacturers have cooperated too closely in the process of obtaining approval.
This USD 56,000 per year Infusion therapy is the first Alzheimer’s disease drug approved in nearly two decades. Biogen claims that the drug is the first to treat debilitating diseases, not just to help patients control their symptoms.
Earlier this month, the FDA’s acting chief took the unusual step of calling for Independent investigation Enter the agency’s interaction with Biogen executives, because there are more and more questions about why the drug is approved.
Biogen’s chief financial officer, Michael McDonnell, said the Massachusetts-based drugmaker welcomes the formal review, which will “help all stakeholders ensure confidence in the therapy.”
Biogen said that Aduhelm’s revenue reached US$2 million in the second quarter, but Vounatsos pointed out that “a significant portion” of sales was inventory, and did not disclose the number of patients who had already started treatment.
MacDonald defended the drug against several claims he called “in fact incorrect,” including that reducing amyloid plaques in the brain would not slow the progression of Alzheimer’s disease.
Aduhelm is around Amyloid hypothesis, Its supporters say that protein clumps that accumulate in the brain can cause Alzheimer’s disease.
Many pharmaceutical companies have previously tried to develop drugs to remove amyloid, but failed, and proved that removing the protein can alleviate the disease.
“There is no reason to use the failure of these antibodies as a reason for disapproval [Aduhelm],” said MacDonald, who said there is no evidence that those other treatments actually remove amyloid.
He also said that the company’s post-mortem analysis was actually incorrect. After the independent committee found that the drug was ineffective, Biogen’s clinical trials were initially stopped in March 2019. The company later presented a new analysis that said the treatment was successful when taken at higher doses.
MacDonald said that people believed that approval of the drug would lead to reduced investment in other Alzheimer’s treatment research, which contradicted precedent, and cited the history of research on HIV and multiple sclerosis.
Biogen’s sales in the second quarter fell by 25% compared with the same period last year to $2.8 billion. According to FactSet’s data, analysts had expected earnings of $2.6 billion.
Biogen shares rose 1.4% in early New York trading on Thursday.