Some statisticians of the FDA had argued the approval of Biogen’s drug but were overruled by high-ranking officials who accelerated the clearance of the drug.New documents released by the FDA in the context of its approval for the Alzheimer’s Drug depict in-depth how the FDA officials were not in agreement as the agency officials were concerned about the controversial new treatment for Alzheimer’s disease.
Through the documents, it is understood that the FDA that was responsible for evaluating the statistical analysis of the drug tests was not sure that there was enough evidence for approving the drug. The drug, now called Aduhelm, has developed pharmaceutical companies Biogen in collaboration with Eisai.But the internal documents and memos that were posted by the FDA reveal that only a few officials had disagreed with the approval.
The application and the data, including the evidence summited for the drug, are greatly scrutinized and have captured tremendous attention. As the drug fails to achieve the medical needs and the people who are eligible for the treatment.The application is now rigorously discussed by scientists, including the FDA team members that reviewed the application.FDA did not release other important technical documents, and important statistical reviews were also not posted. FDA moved faster than usual in making the summary review public.