BIOGEN’S NEW ALZHEIMER’S DRUG ADUHELM (ADUCANUMAB): A BUILDING BLOCK IN DEBATEby John G. Baresky on 06/27/21
FDA approves Aduhelm: the beginning of a new healthcare and pharmaceutical industry controversy involving Alzheimer's
The FDA approved Biogen's (NASDAQ: BIIB) new drug Aduhelm on June 7, 2021. It is the first new Alzheimer's drug in about 20 years. Aduhelm's approval has triggered controversy and hope for patients, medical professionals, research organizations and payers across the healthcare industry.
These are some of the other primary treatment options available to treat Alzheimer's leading up to Aduhelm's approval:
- Aricept (donepezil) - Eisai and Pfizer
- Exelon (rivastigmine) - Novartis (now available as a generic)
- Namenda (memantine) - Allergan (now part of AbbVie)
- Namzaric (donepezil and memantine) - AbbVie
- Razadyne (galantamine) - Janssen - Johnson & Johnson (now available as a generic)
Each of these are viable therapies but ultimately fall short of the goals that medical professionals have to prevent Alzheimer's plus stop or reverse its progression.
The news of Biogen's approval has reinvigorated global interest in Alzheimer's even as the COVID-19 pandemic holds the main stage as it continues to unfold in new directions worldwide.
The controversy behind Aduhelm
Several issues are aligned with Aduhelm from the start. They include:
- The FDA issued Biogen a wide indication within its approval; Aduhelm can be prescribed at almost any phase within an Alzheimer's patient's diagnosis
- Biogen's ballpark price for an annual course of Aduhelm therapy is $50,000
- The clinical data submitted by Biogen to the FDA for Aduhelm's approval is deemed to be inadequate by some who believe there was not enough conclusive evidence to prove the product had clear therapeutic value
All of these considerations and more are contributing to clinical, financial and regulatory debate across the U.S. and worldwide healthcare industry.
The hope behind Aduhelm
Alzheimer's has globally challenged patients, medical professionals, clinical research organizations and the pharmaceutical industry for decades.
About 6 million people in the U.S. have been diagnosed with Alzheimer's among at least 50 million people worldwide who are estimated to be affected by it.
Progress towards effective treatment and a cure for Alzheimer's has been a lengthy process. Aduhelm's approval does have positive aspects:
- Biogen is required to provide extensive additional patient data to the FDA in order for the agency to uphold Aduhelm's approval status and its indication
- Clinicians and Biogen will be scrutinizing Aduhelm patient outcomes closely and building not only more knowledge about the drug but also the patients it is administered to
- Aduhelm is new; once it is prescribed to a greater number of patients its short and long term performance and efficacy will be established
- As new products are being developed for Alzheimer's (such as Eli Lilly's donanemab), they and Aduhelm will be able to further demonstrate their individual treatment attributes and potentially serve as building blocks for future therapies and/or as co-therapies to augment each other's efficacy
Let's continue to put Aduhelm under the microscope and learn from its performance. It is not an inexpensive lesson to gain experience and knowledge from but it is a building block.
Healthcare professionals, clinical research organizations and the pharmaceutical industry have started with nothing before and together have developed an incredible array of new drugs, vaccines, gene therapies and other mission-critical patient care treatment options over decades and centuries of work.
Let's be positive that the Alzheimer's drugs produced 20 years ago and Aduhelm are pivotal steps forward in the development of decisively effective and safe therapies yet to come.