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The Food and Drug Administration (FDA) approval is considered the GOLD standard to know that you should be able to trust a product. TheAPPROVAL OF THE AGENCY means that a drug has been carefully tested and judged safe and efficient, with its advantagesProvide the potential risks. In general, the FDA decision is consistent with the advice of doctors and researchers on the ground, but there are some exceptions. In fact, the FDA has just approved a new medicine against the opinion of external experts. Read more about this controversial medicine.

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On June 7, the FDA approved AduHelm (Aducanumab), a medicine designed to treat Alzheimer's disease. According toA declaration of the FDA, this is the first time the agency has approved a drug for Alzheimer since 2003. The approval comes after an external advisory group urged the FDA to reject the drug in November because it had Not demonstrated to help slow the slowdown progression of the disease.

NBC News reported that although the drugclaims that this can slow down the decline rate In Alzheimer's patients, it was only shown to do so in a study that the Panel did not feel was substantial evidence. The panelists also noted several "red flags" on the injectable treatment.

LON SCHNEIDER, MD, Director of the Alzheimer California California Center at the University of Southern California and one of the site investigators on a trial of Aducanumab, saidThe New York Times, "There is so muchlittle evidence for efficiency ... I do not know what caught the fantasy of the FDA here. "

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In the midst of all the controversy, the FDA requires that the drug, the biogenic, ofconduct a follow-up study, the associated press (AP) reported. If the study does not demonstrate efficiency, the FDA could eliminate the market drug. However, the AP note that the Agency rarely takes this action.

The FDA has already recognized the conflict surrounding its recent decision. In a statement, the Director of the FDA Evaluation and Drug Research Center and Research CenterPatrizia Cavazzoni, MD, noted that the agency was "well aware of theAttention surrounding this approval. "She added that" the community of experts offered different perspectives "and submission data left uncertainties as to the provision of the drug.

Jason Karlawish, MD, Co-Director of the CENC Memory Center and on-site investigator for the medicine biogen clinical trials, told NBC News thatHe does not agree with the decision of the FDA. "It will present a real challenge for patients and caregivers and clinicians about to prescribe the drug," said Karlawish. "This will also have difficulties for researchers who conduct tests and consider testing to develop better drugs". For his part, he stated that he only prescribed the drug only "after having a conversation with the patient members and the family of the notable uncertainties that surround if the medicine works even".

According toThe New York TimesExperts feel even though drugs have been able to slow down the cognitive decline of some, the benefit would be so minimal that it would not exceed the risk of swelling or bleeding in the brain that the drug caused in some patients during the tests.

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Although Biogen has not yet disclosed how much the drug will, the AP indicated that estimates say it could be $ 30,000 to $ 50,000 for a year of treatment. At the same time, a preliminary analysis was made that the drug should only be evaluated from $ 2,500 to $ 8,300 a year to be a good value based on "small global health gains". The PA, the non-profit institute of the clinical and economic examination considered that "any price is too high" if the delivery of the drug is not confirmed in follow-up studies.

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