Yes of the US to drug against Alzheimer’s, Pani (formerly Aifa): “A brave choice from Fda”

Yesterday’s green light in the US for anti-Alzheimer aducanumab, “after 18 years and after more than 260 failed clinical trials and nearly $ 300 billion spent without results”, “was not” an “easy” decision. But “I personally believe that the FDA has made the right and courageous choice, giving early and controlled access to a therapy that is potentially very useful for patients and their families”. Luca Pani, former director general of the Italian drug agency Aifa, underlines this to Adnkronos Salute, now a professor at the University of Miami in the States and Modena in Italy. Aducanumab is a monoclonal antibody and, explains Pani to Adnkronos Health, the approval granted by the FDA “is significant for many reasons. It is the first therapy approved for this disease directed against cerebral beta-amyloid plaques, which is one of the mechanisms that are thought to cause the disease. Another noteworthy consideration is the fact that the FDA has chosen to use an accelerated approval path, whereby a drug can be approved for a serious or life-threatening disease when it demonstrates a significant therapeutic benefit over existing treatments, using a surrogate target of clinical benefit that is reasonably likely to predict, while uncertainties remain about the drug’s overall clinical benefit that will need to be clarified during its use in the coming months. ” Europe and on the drug agency Ema. And Pani too was already looking in this direction, commenting last night via Twitter on the news of the FDA green light to the drug: “Now – he pointed out – opportunities and challenges will emerge. The first: what will Ema do?”. The US “was not an easy choice”, Pani reiterates, “because the data included in the presentation of the pharmaceutical company that requested this approval were very complex and left some uncertainty about the total clinical benefit, so much so that the scientific community However, the expedited approval option had never been discussed by the FDA’s own advisory committee. Treatment with this novel monoclonal antibody has clearly been shown in all studies to substantially reduce beta-amyloid plaques. of the plaques is likely to translate into a clinical benefit, as it was enough for the FDA to approve “. In the end, concludes the former DG Aifa,” as regulators always have to do, the US agency has concluded that the benefits of a aducanumab-based therapy for patients with Alzheimer’s disease outweighed the risks. “