Aduhelm (aducanumab), a novel drug that promises to fight Alzheimer’s, has been approved for use by the US Food and Drug Administration (FDA).

The drug was allowed using the accelerated approval pathway, which can be used for a drug for a serious or life-threatening illness that provides a significant therapeutic advantage over existing treatments. Alzheimer’s is a degenerative neuronal disease that affects millions of people around the world, in the US an estimated 6.2 million affected patients.

“Alzheimer’s disease is a devastating disease that can have a profound impact on the lives of those diagnosed with the disease, as well as their loved ones,” said Patrizia Cavazzoni, MD, director of the Center for Drug Evaluation and Research at the FDA in a press release released by the federal agency itself.

“Currently available therapies only treat the symptoms of the disease; This treatment option (Aduhelm) is the first therapy to target and affect the underlying disease process of Alzheimer’s disease. As we have learned from the fight against cancer, the accelerated approval pathway can bring therapies to patients more quickly and, at the same time, stimulate more research and innovation.”

Alzheimer’s is a progressive, irreversible brain disorder that slowly destroys memory and thinking skills, and eventually the ability to perform simple tasks. While the specific causes of Alzheimer’s disease are not fully understood, it is characterized by changes in the brain, including amyloid plaques and neurofibrillary tangles, or tau, that cause the loss of neurons and their connections. These changes affect a person’s ability to remember and think.

Aduhelm represents the first treatment of its kind approved for Alzheimer’s disease. It is the first new approved treatment for Alzheimer’s disease since 2003, and it is the first therapy to focus on the underlying pathophysiology of the disease.

The researchers evaluated the efficacy of Aduhelm in three separate studies representing a total of 3,482 patients. The studies consisted of double-blind, randomized, placebo-controlled dose range examinations in patients with Alzheimer’s disease. Patients who received the treatment had a significant dose- and time-dependent reduction in beta amyloid plaque, while patients in the control group of the studies had no reduction in beta amyloid plaque.

The drug’s side effects included temporary swelling in areas of the brain that usually resolves over time and causes no symptoms, although some people may have symptoms such as headache, confusion, dizziness, vision changes, or nausea. Another warning for Aduhelm is the risk of hypersensitivity reactions, including angioedema and hives.

The drug Aduhelm is manufactured by the American multinational biotechnology company Biogen Inc, which is based in Cambridge, Massachusetts. This scientific laboratory specializes in the discovery, development and delivery of therapies for the treatment of neurological diseases.

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