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Food and Drug Administration Narrows Information for Alzheimer’s Patients

The US Food and Drug Administration has restricted the group of Alzheimer’s patients who should receive the controversial drug aducanumab. The FDA approved changing the drug’s label to clarify that the treatment is intended for the patients with mild cognitive impairment or milder stages of the disease.

Treatment with Aduhelm should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials. There is no safety or effectiveness data on initiating treatment at earlier or later stages of the disease than were studied.Initially, the previous prescribing information for the drug which was approved by the FDA last month noted that aducanumab is indicated to treat Alzheimer’s disease but did not mention a certain stage of the disease.

Dr Alfred Sandrock, Jr., head of research and development at Biogen said that based on the company’s ongoing conversations with prescribing physicians, FDA and patient advocates. They submitted this label update to further clarify the patient population that was studied across the three Aduhelm clinical trials that supported approval.

We are committed to continuing to listen to the community’s needs as clinical practice adapts to this important, first-in-class treatment option, said in the company’s announcement.In June, the FDA approved aducanumab using its accelerated approval program, which allows for the earlier approval of a drug for a serious or life-threatening illness even though more study into the drug’s benefits may be needed.

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