FDA Defends The Controversy Of The New Drug Aduhelm Approval

FDA Defends The Controversy Of The New Drug Aduhelm Approval

The Food and Drug Administration has approved a new drug for people who are suffering from Alzheimer’s disease. It is known that Alzheimer’s disease is a serious neurodegenerative disease that starts slowly and takes over progressively. Earlier, there were no drugs or treatments for this disease, but recently the Food and Drug Administration has approved a new drug named Aduhelm. The last time when drug approved by the United States Food and Drug Administration was back in 2003 it is almost nearly two decades ago and in a controversial decision that left the agency defending its reputation and its science. 

FDA Defends The Controversy Of The New Drug Aduhelm Approval

It is also believed that the drug Aduhelm treated Alzheimer’s disease by clearing out the amyloid-beta, a sticky protein known to form plaques in the brain of early-stage patients. It is also believed that this is the first dug in the medical field that is meant to attack the suspected root cause of Alzheimer’s disease. Other drugs in the market only targets the symptoms and does not slow down the disease progression, but this drug is believed to do that so. Dr. Patrizia Cavazzoni, director of the Food and Drug Administration Center for Drug Evaluation and Research, also mentioned that the FDA has approved the drug under the accelerated approved pathway, which does not require any conclusive proof that a drug provides.

FDA Defends The Controversy Of The New Drug Aduhelm Approval

She also explained that instead of the accelerated approval, the FDA can issue conditional approval if the drug is shown to modify a key process in a disease and that this change is reasonably likely to help patients. She also stated that they determined the drug favorably modifies a key pathological produces, that reduces the amount of amyloid plaque in the brains of these patients with Alzheimer’s disease and this improvement is reasonably likely to predict the clinical benefit of the drug.

In approving, the FDA ran counter to its advisory committee of experts, which votes 10 out of 11 against approving Aduhelm, as well as other Alzheimer’s experts that included some of the doctors who ran the drug’s clinical trials in hospitals across the nation. The director of health research for Public Citizen, a nonprofit consumer watchdog group, mentioned that the FDA’s approval shows a stunning disregard for science and eviscerates the agency’s standards for approving new drugs. This action of the Food and Drug Administration has damaged the credibility and the reputation has been damaged. But the other Associations, such as Alzheimer’s Association hailed the FDA’s decision as opening the way to more extensive research into chronic brain diseases.

The chief science officer for the Alzheimer’s Association mentioned that the Food and Drug Association drug approval ushers in a new era in Alzheimer’s treatment and research. History has shown that approvals of this drug in a new category invigorate the field, increases investments in new treatments, and encourages greater innovation. We are hopeful that this is the beginning – both for this drug and for better treatments for Alzheimer’s disease.

Cavazzoni said that the drug’s developer, Biogen, is required to conduct follow-up tests and prove that the drug works to slow down the progression of Alzheimer’s disease. She also mentioned that they expect this study to be conducted on time and if this study is not conducted on time, the following administrative process, withdraw this approval therapy. Aduhelm had a rocky journal approval, with Biogen shutting down a pair of the clinical trials when the FDA advisory committee decided that the drug did not work well and hence it does not make any difference to the patients with Alzheimer’s disease. But seven months later, Biogen reversed the drugs and then applied for the approval of the drug, based on the more extensive analysis that showed the drug had some positive effect for patients at higher doses.

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