New Alzheimer’s therapy: FDA has its own decision examined

An Alzheimer’s drug that is used at an early stage to prevent the disease from progressing? That sounds wonderful. It would be a milestone because the remedies available so far only alleviate symptoms of the disease. But since the US company Biogen announced that it had developed such a drug, the inconsistencies and irritations have been increasing. Another astonishing volte occurred over the weekend: The US Food and Drug Administration (FDA) felt compelled to have the work of its own employees checked, who had approved the drug with the trade name Aduhelm a month ago. There is suspicion that FDA decision-makers maintained unusually close contacts with the manufacturer.

The incumbent FDA boss Janet Woodcock therefore asked an independent investigative commission of the US Department of Health to examine the processes surrounding the approval “as soon as possible”. She cited reports of numerous contacts between Biogen and the FDA – “including some that may have occurred outside of formal communication.” The allegations could undermine public confidence in the FDA’s decision, Woodcock said. Therefore, it must be checked whether there have been contacts that are incompatible with the rules and procedures of the authority.

The US web portal Statnews had previously reported that there was an informal meeting between a Biogen representative and an FDA senior officer involved in the approval process prior to the approval process. During the approval process, the formal cooperation is said to have been noticeably close, and there was talk of almost daily contacts. According to media reports, it was also unusual that FDA staff and Biogen jointly presented the study data to the agency’s scientific advisory board.

The scientific advisors advised against the launch, the FDA did not listen

This committee was not convinced by the presentation and spoke out against the market launch. Nevertheless, the FDA approved the agent, a monoclonal antibody. To do this, it used an accelerated procedure that also takes indirect indications of effectiveness into account. As such evidence, she assessed that the drug reduced the protein deposits in the brains of the study participants that are typical for Alzheimer’s disease. It remained open, however, to what extent this finding is actually reflected in an improved mental performance. The data that Biogen presented on the cognitive performance of the test subjects were contradicting and ultimately inconclusive. Biogen originally discontinued its approval studies because they seemed so hopeless, but later assumed they would be effective after a new analysis of the data.

Just a few days ago, the FDA reacted to another irritation. Although Aduhelm had only been tested on patients with early disease, the agency had approved it for all Alzheimer’s patients. Now she revised the decision and made it clear that the drug should only be prescribed to sick people with mild symptoms, as there is no knowledge about effects and side effects in patients who receive it at an earlier or later stage of the disease. The number of potential buyers is therefore shrinking considerably – and so is the manufacturer’s profit prospects. The monthly infusion treatment costs $ 56,000 per patient annually.