Biogen has put up a strong defense against the science and approval process behind its controversial Alzheimer’s drug, saying “misinformation” is fueling criticism of the treatment.
The drug company has come under increasing criticism after its Alzheimer’s drug was approved by the US Food and Drug Administration last month.
Biogen CEO Michel Vounatsos said in a 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 on very solid grounds and represented the right thing to do,” he said.
Some scientists have said the treatment isn’t working and should never have been given the green light, while others argue that the US drug regulator and drug maker had worked too closely in the run-up to approval.
The $56,000 per year infusion treatment is the first Alzheimer’s drug to receive 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 a… independent investigation in the agency’s interactions with Biogen executives, as questions mount about 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 Aduhelm’s second-quarter revenue was $2 million, but Vounatsos noted that a “large portion” of sales were inventory and did not reveal the number of patients who had started treatment.
McDonnell defended the drug against several claims he called “factually false,” including that reducing amyloid plaques in the brain does not result in slowing the progression of Alzheimer’s disease.
Aduhelm is designed around the amyloid hypothesis, whose proponents say that clumps of protein that build up in the brain cause Alzheimer’s disease.
Numerous pharmaceutical companies have tried to develop amyloid-clearing drugs before, but have failed to prove that removing the proteins can alleviate the disease.
“There is no basis to use 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 the claims that the company conducted post-hoc analyzes were factually false. Biogen’s clinical trials were initially halted in March 2019 after an independent committee found the drug to be ineffective. The company later presented a new analysis stating that the treatment was successful at a higher dose.
McDonnell said people who believed approval of the drug would lead to less investment in research into other Alzheimer’s treatments “contrary to the precedent,” citing the history of research into HIV and multiple sclerosis.
Biogen’s second quarter revenue declined 25 percent compared to the same period last year to $2.8 billion. Analysts had expected earnings of $2.6 billion, according to FactSet.
Shares of Biogen rose 1.4 percent in morning trading in New York on Thursday.