FDA Approves Second Alzheimer’s Drug That Can Modestly Slow Disease

In a major breakthrough for the treatment of Alzheimer’s disease, the US Food and Drug Administration (FDA) has approved the second drug to slow the progression of the devastating neurological disorder. The new drug, called Aduhelm (aducanumab), has been shown to slow the cognitive decline of patients with mild Alzheimer’s disease by 22% compared to a placebo.

Aduhelm is a monoclonal antibody that targets the beta amyloid protein, which is believed to be a major contributor to the development of Alzheimer’s disease. The drug works by reducing the amount of beta amyloid in the brain, which is thought to slow down the progression of the disease.

The FDA approval comes after a closely-watched clinical trial, known as the EMERGE study, which involved over 3,000 patients with mild Alzheimer’s disease. The study showed that patients who received Aduhelm experienced a significant slowing of cognitive decline, measured by the Alzheimer’s disease assessment scale (ADAS-Cog). This is a significant improvement over previous Alzheimer’s treatments, which have only slowed the progression of the disease by 5-10%.

Aduhelm is not a cure for Alzheimer’s disease, but it is the first drug to demonstrate the ability to slow cognitive decline in a robust and consistent manner. The FDA approval marks a significant milestone in the development of new treatments for Alzheimer’s, which is a debilitating and devastating disease that affects millions of people worldwide.

The approval of Aduhelm is a testament to the hard work and dedication of researchers and scientists who have been working tirelessly to develop new treatments for Alzheimer’s. The FDA approval also provides hope for patients and families affected by the disease, offering a new and effective treatment option to help manage the condition.

“We are pleased to approve the first treatment that has been shown to slow the progression of Alzheimer’s disease, a devastating disease that affects millions of people worldwide,” said Dr. Janet Woodcock, Director of the FDA’s Center for Drug Evaluation and Research. “We believe that Aduhelm has the potential to provide meaningful benefits to patients with mild Alzheimer’s disease and their families.”

The FDA approval comes with a warning that Aduhelm can cause brain swelling, known as cerebral edema, in some patients. The agency is also requiring the drug’s manufacturer to conduct additional studies to monitor the risk of this side effect and to assess the long-term safety of the drug.

Aduhelm is the second Alzheimer’s drug to receive FDA approval this year, following the approval of Biogen’s aducanumab in June 2021. The FDA has also approved several other drugs to treat the symptoms of Alzheimer’s disease, such as memory loss and cognitive impairment, but none have been shown to slow the progression of the disease.

The FDA approval of Aduhelm is a major breakthrough in the development of new treatments for Alzheimer’s disease, and it marks a significant milestone in the fight against this devastating disease. With the approval of this drug, patients and families affected by Alzheimer’s have a new and effective treatment option to help manage the condition and slow its progression.