Biogen’s Aducanumab Spring 2021 March 7, 2021,

by redpill Thu Aug 27, 2020 5:12 pm

Thu Aug 27, 2020 5:00 pm

in the news,

FDA Accepts Biogen’s Aducanumab Biologics License Application for Alzheimer's Disease with Priority Review
August 7, 2020 at 7:30 AM EDT

Priority Review accelerates FDA review time, with a Prescription Drug User Fee Act (PDUFA) target action on March 7, 2021
If approved, aducanumab would be the first treatment to meaningfully change the course of Alzheimer’s disease

CAMBRIDGE, Mass. and TOKYO, Aug. 07, 2020 (GLOBE NEWSWIRE) -- Biogen (Nasdaq: BIIB) and Eisai, Co., Ltd. (Tokyo, Japan) today announced that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for aducanumab, an investigational treatment for Alzheimer’s disease. The application has been granted Priority Review, with a Prescription Drug User Fee Act (PDUFA) action date on March 7, 2021, and the FDA has stated that, if possible, it plans to act early on this application under an expedited review. 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.

“The FDA’s acceptance of the aducanumab BLA with Priority Review is an important step in the path to potentially having a treatment that meaningfully changes the course of Alzheimer’s disease,” said Michel Vounatsos, Chief Executive Officer at Biogen. “We look forward to working with the FDA throughout the review process and thank the thousands of clinicians, patients and caregivers who participated in our clinical trials and have accompanied us on this journey. We believe that aducanumab marks the beginning of a new era of potential treatments for Alzheimer’s disease that will inspire even more discovery and innovation to bring hope to those affected by this devastating disease.”

“Reducing clinical decline and maintaining the ability to live an independent life for as long as possible are things that people living with Alzheimer’s disease and their families value in a potential treatment,” said Dr. Haruo Naito, Chief Executive Officer at Eisai Co., Ltd. “If aducanumab is approved, we expect that it will make a difference in the lives of people living with Alzheimer’s disease. We believe that this historic milestone is one step towards creating a paradigm shift in treatment for Alzheimer’s disease, a public health issue for aging societies.”

Biogen did not use its Priority Review voucher for the aducanumab BLA. The FDA also stated that it is currently planning to hold an Advisory Committee meeting for this application on a yet-to-be-determined date.

https://investors.biogen.com/news-releases/news-release-details/fda-accepts-biogens-aducanumab-biologics-license-application

I'm following this closely. if my mother is still alive in this time frame, March 7, 2021, and that's a big if, I'll try to obtain this for her ASAP.

first it has to be FDA approach which may or may not occur, then I have to figure out how to obtain it and pay for it. she does have medicare.

today is s Thu Aug 27, 2020 5:00 pm

Biogen hopes an FDA response March 7, 2021,

i wonder

can a regularly internal medicine doctor do this in the regular clinic where she gets her type 2 meds such as metformin prescribed or do i have to see a specialist, a neurologist, and go to a hospital or specialized clinic?

and how will it be covered?

how soon after March 7, 2021, can my mother get this drug if approved assuming she is still alive and healthy?

it's too bad that either my mom develops alzheimer's at age 97, which would be 2040 (!) as she is 77 now, OR these drugs weren't developed in the late 80s or early 90s, so that by now, they would be generic and much less expensive.

most of her meds from simvastatin (zocor) to metformin (glucophage) were name brand and expensive medications, but now all generic, all cheap many zero copay, and negligible effect on the donut hole in medicare.

a year supply of metformin amounts to like $9 out of a $4000 deductible before we enter the medicare coverage gap

oh well.

I marked March 7, 2021 on my calendar.

seems like it falls on a Sunday.