US Approves Drug for Treatment of Alzheimer’s Disease

The Food and Drug Administration of the United States has approved a drug for the treatment of Alzheimer's disease, a significant decision that will alter the treatment regimen for the memory disorder. In the United States, Alzheimer's disease is the sixth largest cause of death.

Reuters reported that US regulators approved Biogen Inc.'s Aducanumab as the first treatment for Alzheimer's disease on Monday, amid debate about the drug's mixed clinical trial findings. The medicine will be sold under the brand name Aduhelm, and the corporation expects to make billions of dollars from it.

“We are well-aware of the attention surrounding this approval,” Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said in a press release. “We understand that Aduhelm has garnered the attention of the press, the Alzheimer’s patient community, our elected officials, and other interested stakeholders.

Aducanumab is designed to remove sticky deposits of a protein called amyloid beta in the brain, which is believed to be a cause of Alzheimer’s disease. Most of the drugs designed for Alzheimer’s have attempted to clear these plaques.

The now-approved drug, Aducanumab, appears to do this in some patients, but only at an early stage in the disease.

Approval of this medication means that early testing would be encouraged to establish that a patient may have the disease. Patients with early memory problems will need scans of the brain to establish whether they have amyloid plaques.

With Biogen estimating that around 1.5 million Americans would be eligible for treatment with Aducanumab, which is given by monthly infusion, concerns are raised as to the running costs and how it will affect the healthcare system, as it requires not only equipment but also trained staff.

The healthcare community is pided over Biogen’s drug, with some neurologists eager to have an effective option for patients with the lethal disease, which includes deteriorating memory loss and the ability to care for oneself, and other doctors noting that the clinical trial results were inconsistent and more proof would be needed.