FDA Has Approved Groundbreaking Alzheimer’s Drugs

Jul 02, 2023 at 11:13 am by Alex

FDA Has Approved Groundbreaking Alzheimer’s Drugs

FDA Has Approved Groundbreaking Alzheimer’s Drugs

FDA has approved groundbreaking Alzheimer’s drugs. Alzheimer’s disease can cause enormous damage in the lives of patients, their loved ones, and caregivers. Dealing with heartbreak and daily challenges, such as memory loss, loss of identity, and the gradual fading of the person they once knew, can interrupt entire families as they attempt to care for their loved ones as the disease worsens.

Paving the way for hope are two groundbreaking drugs designed to fight the impact of Alzheimer's by successfully slowing down the disease. These medicines, known as Leqembi and donanemab, have both received full approval from the FDA, citing an astonishing milestone in medical history as it is the first time a drug intended to slow the evolution of Alzheimer's disease has been granted complete regulatory approval.

The FDA Has Approved Groundbreaking Alzheimer’s Drugs

The FDA has approved groundbreaking Alzheimer's drugs that target the disease itself and not just its symptoms. Leqembi, developed by Eisai in Japan and Biogen in the U.S., focuses on a brain protein called beta-amyloid, which has historically been considered one of the underlying causes of Alzheimer's.

On the other hand, Donanemab, created by American pharmaceutical company Eli Lilly, is an antibody therapy that targets irregular clumps of beta-amyloid protein in the brain, which are recognized as one of the pathological trademarks of Alzheimer's disease. The medication binds to the abnormal amyloid, which removes it from the brain. It acts swiftly and can eliminate nearly 90% of amyloid plaque, thus reducing potential brain damage and effectively slowing the rate of cognitive decline. In a study involving 1,700 people, disease progression was slowed by an extraordinary 35%, making it the most significant effect ever observed in a trial for an Alzheimer's disease-modifying drug.

Donanemab And Leqembi

Both Donanemab and Leqembi share similar calming targets but employed distinct trial designs. While these drugs do not offer a cure for Alzheimer's disease, the possibility for them to slow cognitive decline significantly enhances patients' quality of life. By helping patients to live more independently, enjoy their hobbies and loved ones, and maintain their well-being, the medications allow them to experience a more meaningful and fulfilling life.

Regarding safety, Leqembi's approval by the FDA comes with its strongest warning label—a boxed warning—highlighting specific side effects such as brain swelling and hemorrhage, and the possibility of seizures and death. Furthermore, patients are advised to undergo genetic testing before starting the medication to assess their risk for these side effects.

As for Donanemab, the medical community will closely monitor approaching trial results for a side effect known as ARIA-E, a type of brain swelling that is usually reversible but can be severe.

The Results

The results from both drugs provide compelling evidence that removing amyloid from the brain can effectively slow down Alzheimer's disease, especially when treatment is initiated earlier during the relatively healthy stages of patients' brains. This explains why the FDA has approved groundbreaking Alzheimer’s drugs, Donanemab and Leqembi.

With this combination of effective medicines, early detection and treatment, and lifestyle management for Alzheimer's patients, we seem to be moving toward a new era of hope and healing for those affected by this devastating condition.

If you have concerns about your brain health, consider discussing your symptoms and potential next steps with your primary care physician. Remember, taking care of your body, mind, and spirit is essential to achieving overall well-being.