Biogen pens open letter to Alzheimer’s community
pharmafile | July 23, 2021 | News story | Medical Communications |
In the wake of the controversial approval of Biogen’s Alzheimer’s drug, Aduhelm, the company has penned an open letter to the Alzheimer’s community.
The drug has come under a lot of criticism from experts, charities, and members of the public. Three panel FDA panel members who voted against the drug’s approval resigned in protest.
In the letter, Alfred Sandrock, Head of Research and Development, said: “The approval of ADUHELM by the US Food and Drug Administration came after an extensive development, testing, and review process.
“Over more than a decade, we at Biogen engaged in rigorous and science-driven research and development that assessed whether Aduhelm could help patients worldwide who suffer from Alzheimer’s disease.
“We are proud of the work our dedicated team has done to develop Aduhelm, and of the potential it brings to Alzheimer’s patients. We are equally proud of the professionalism both our team and the FDA demonstrated during a thorough review process.”
Dr Sandrock then addressed the controversy that has been at the forefront of Aduhelm, “Unfortunately, Aduhelm’s approval has been the subject of extensive misinformation and misunderstanding.
“It is normal for scientists and clinicians to discuss data from experiments and clinical trials, to debate, and to disagree, on the interpretation of data. That is how science advances and we welcome these discussions. Recently, however, there has been a turn outside the boundaries of legitimate scientific deliberation.
“We welcome a formal review into the interactions between the FDA and Biogen on the path to the approval of aducanumab.”
The letter then goes on to explain the process of accelerated approval, that it is “factually incorrect” that the drug does not demonstrate benefits, and the “rigour” underlying the FDA’s analysis.
There is also an emphasis that the approval of Aduhelm is helping pave the way for other Alzheimer’s drugs.
Dr Sandrock said: “We recognise that Aduhelm’s dataset was complex and its journey to this point did not follow a conventional path. But the road to innovation is rarely straightforward, and Aduhelm is not an exception.
“Throughout, our team has worked with steadfast determination to follow the science and be driven by an acute understanding of the pain and suffering Alzheimer’s disease inflicts on patients, families, and society. We stand behind the clinical evidence provided by the studies and the data-driven scientific approach taken.
“We will continue to put science first, be transparent with our data and do all we can to assure that physicians have accurate, and complete information on which to base the important decisions regarding their patients’ care.”
There is currently a formal review being undertaken by the FDA into the process behind the approval, and calls have been made from a former panel member for further investigation.