loader image
Saturday, February 24, 2024
76.7 F
McAllen
We Welcome your Press Release
- Advertisement -

FDA Alzheimer’s Drug Gets Accelerated Approval, but today FDA adds restrictions

Translate to Spanish or other 102 languages!

Mega Doctor News

- Advertisement -

UPDATE: The FDA has now issued restrictions to this treatment.

The U.S. Food and Drug Administration approved Aduhelm (aducanumab) for the treatment of Alzheimer’s, a debilitating disease affecting 6.2 million Americans. Aduhelm was approved using the accelerated approval pathway, which can be used for a drug for a serious or life-threatening illness that provides a meaningful therapeutic advantage over existing treatments. Accelerated approval can be based on the drug’s effect on a surrogate endpoint that is reasonably likely to predict a clinical benefit to patients, with a required post-approval trial to verify that the drug provides the expected clinical benefit. 

The updated label now states that aducanumab should be initiated only in patients with mild cognitive impairment (MCI) or mild dementia stage of disease — the population in which treatment was initiated in the clinical trials leading to approval of the anti-amyloid drug.

- Advertisement -

“Alzheimer’s disease is a devastating illness that can have a profound impact on the lives of people diagnosed with the disease as well as their loved ones,” said Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research. “Currently available therapies only treat symptoms of the disease; this treatment option is the first therapy to target and affect the underlying disease process of Alzheimer’s. As we have learned from the fight against cancer, the accelerated approval pathway can bring therapies to patients faster while spurring more research and innovation.”

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

Aduhelm represents a first-of-its-kind treatment approved for Alzheimer’s disease. It is the first new treatment approved for Alzheimer’s since 2003 and is the first therapy that targets the fundamental pathophysiology of the disease.

UPDATE: The FDA has now issued restrictions to this treatment.

- Advertisement -
- Advertisement -

- Advertisement -

More Articles

Creating a Bioartificial Kidney as a Permanent Solution to Kidney Failure

The Kidney Project national research team is being led by Shuvo Roy, PhD, a bioengineer and faculty member in the Department of Bioengineering and Therapeutic Sciences, Schools of Pharmacy and Medicine, University of California, San Francisco (UCSF). The project is co-directed by William Fissell, MD, at Vanderbilt University Medical Center.

Dr. Ashley Bose Honored by The RGV Hispanic Chamber of Commerce

The RGV Hispanic Chamber of Commerce women's committee celebrated the 2023 winners of the Women of Distinction. This was an outstanding presentation where all the ladies were chosen from over 35 candidates.

World-Renowned Bariatric Surgeon Joins DHR Health

Mega Doctor News EDINBURG, Texas – DHR Health Bariatric and Metabolic Institute is...

Ashley Pediatrics OPENS 14th Clinic in the Valley

The Bose family is dedicated and committed to making a difference in the health and education of the Valley's people; this passion drives them.
- Advertisement -
×