First-of-its-Kind Alzheimer’s Drug is Pending FDA Approval After Patients Experienced Marked Cognitive Improvement
By Good News Network -Oct 23, 2019
There is currently no drug treatments on the market that can slow the progression of Alzheimer’s disease—but this new medication could soon be a groundbreaking treatment for dementia patients after researchers examined the data from the drug’s Phase 3 clinical trials.
This week, pharmaceutical company Biogen announced that—after consulting with the U.S. Food and Drug Administration (FDA)—they plan to pursue regulatory approval for aducanumab: an investigational treatment for early Alzheimer’s disease.
New analysis showed that aducanumab reduced clinical decline in patients with early Alzheimer’s disease as measured by the pre-specified clinical endpoints. Based on discussions with the FDA, the Biogen pharmaceutical company plans to submit a licensing application for the drug in early 2020. They also aim to offer aducanumab to eligible patients previously enrolled in clinical studies.
Patients who received aducanumab experienced significant benefits on measures of cognition and function such as memory, orientation, and language. Patients also experienced benefits on activities of daily living including conducting personal finances, performing household chores such as cleaning, shopping, and doing laundry, and independently traveling out of the home.
If approved, aducanumab would become the first therapy to reduce the clinical decline of Alzheimer’s disease and would also be the first therapy to demonstrate that removing amyloid beta resulted in better clinical outcomes.
“With such a devastating disease that affects tens of millions worldwide, today’s announcement is truly heartening in the fight against Alzheimer’s,” said Biogen CEO Michel Vounatsos. “This is the result of groundbreaking research and is a testament to Biogen’s steadfast determination to follow the science and do the right thing for patients.
For more information on the study’s results, you can visit the Biogen website for additional details and analysis.
The full article can be found at:
https://www.goodnewsnetwork.org/first-of-its-kind-alzheimers-drug-pending-fda-approval/