Biogen has published a strong defense of the science and approval process behind its controversial Alzheimer’s drug, saying the “disinformation” fuels treatment criticism.
The pharmaceutical company faced growing scrutiny following the approval of its Alzheimer’s drug last month by the U.S. Food and Drug Administration.
Michel Vounatsos, Biogen’s chief executive, said Thursday in a earnings call: “I want to be clear that Biogen is behind the integrity of the review process.”
The treatment, which is sold under the Aduhelm brand, “was appropriately approved for very solid reasons and represented the right thing to do,” he said.
Some scientists have said the treatment doesn’t work and they should never have permission, while others say the U.S. drug regulator and pharmacist have collaborated too closely in preparing the approval.
U $ 56,000 a year infusion treatment is the first Alzheimer’s drug to receive the green light in nearly two decades. Biogen states that the drug is the first to treat the causes of debilitating disease, instead of just helping patients manage their symptoms.
Earlier this month, the FDA chief took the unusual step of calling for one independent investigation in the agency’s interaction with Biogen executives as demands grow because the drug has been approved.
Michael McDonnell, Biogen’s chief financial officer, said the pharmacist in Massachusetts welcomed the formal review and that it would be “good for all those involved to ensure confidence in the therapy.”
Biogen said revenue from Aduhelm made $ 2 million in the second quarter, but Vounatsos noted that a “large chunk” of sales were inventory and did not disclose the number of patients who began treatment.
McDonnell defended the drug against several claims he called “factually wrong,” even though reducing amyloid plaques in the brain does not lead to slowing the progression of Alzheimer’s disease.
Aduhelm is conceived around the amyloid hypothesis, Proponents say the protein clots that develop in the brain cause Alzheimer’s.
Numerous pharmaceutical companies have tried and failed before developing amyloid cleansing drugs and have shown that protein removal can mitigate the disease.
“There is no basis to use the failure of these antibodies as a reason for not approving [Aduhelm], ”Said McDonnell, who said there was no evidence that those other treatments actually eliminated amyloid.
He also said that the claims that the company had conducted post hoc analysis were factually incorrect. Biogen’s clinical trials were initially arrested in March 2019 after an independent committee found that the drug was not going to be effective. The company then presented a new analysis saying that the treatment was successful when it was taken at a higher dose.
McDonnell said people who believe drug approval would lead to less investment in research for other Alzheimer’s treatments are “contradicted by precedents,” citing the history of research into HIV and multiple sclerosis.
Biogen’s second-quarter sales fell 25 percent compared to the same period last year, to $ 2.8 billion. Analysts have expected earnings of $ 2.6bn, according to FactSet.
Shares in Biogen rose 1.4 percent in Thursday morning trading in New York.