139 - They Did What?! FDA Approval of Aducanumab for Alzheimer’s Disease

HelixTalk - Rosalind Franklin University's College of Pharmacy Podcast

Sean P. Kane, PharmD, BCPS

Health & Fitness, Medications, Rosalindfranklin, Rfums, Pharmacy, Pharmd, Pharmacist, Medicine, Drugs

5 • 644 Ratings

🗓️ 16 November 2021

⏱️ 34 minutes

🔗️ Recording | iTunes | RSS

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Summary

In this episode, we discuss the recent accelerated approval of the new monoclonal antibody-based treatment agent, aducanumab (Aduhelm), by the FDA. We dive into the drug approval process, the efficacy and safety data, and the behind-the-scenes story of the FDA approval. Furthermore, we will present the controversy behind the approval and what it means for stakeholders.

Key Concepts

Aducanumab (Aduhelm) is a monoclonal antibody proven to reduce beta amyloid plaques in patients with Alzheimer’s disease.
Despite reducing plaques, aducanumab did NOT result in meaningful cognitive improvements in patients receiving the drugs versus placebo; additionally, the drug was associated with a potentially concerning adverse effect called ARIA-E (amyloid related imaging abnormalities-edema).
Despite an advisory panel unanimously recommending AGAINST approval and a lack of clinical outcome improvement, the FDA did go on to approve the drug in patients with Alzheimer’s disease using an accelerated approval process.
In the episode, we discuss the substantial ramifications of the FDA’s approval primarily in hurting its credibility in validating the safety and efficacy of other medications on the US market.

Transcript

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0:00.0	Welcome to Helix Talk, an educational podcast for healthcare students and providers covering real-life clinical pearls, professional pharmacy topics, and drug therapy discussions.
0:11.0	This podcast is provided by pharmacists and faculty members at Rosal Franklin University College of Pharmacy.
0:17.0	This podcast contains general information for educational purposes only. This is not professional
0:22.4	advice and should not be used in lieu of obtaining advice from a qualified health care provider.
0:27.2	And now on to the show. Welcome to Helix Talk episode 139. I'm your co-host Dr. Kane.
0:35.7	I'm Dr. Patel. And today with us again, we have Dr. Rahul Dishmuk with us.
0:41.6	Hello, everyone. Welcome back, Dr. Dishmuk. Thank you for being here today. And the title of our
0:48.2	episode 139 is they did what? The FDA approval of adiucanumab for Alzheimer's disease.
0:56.8	And in this episode, we're going to briefly talk about what's cooking in the world of
1:03.9	Alzheimer's disease, but really focus on this recently approved, I would say, accelerated
1:09.4	approval of the new monoclonal antibody-based treatment
1:13.3	adiucanumab or adi-home by FDA.
1:16.9	And we're going to kind of drive into the approval process, briefly review the efficacy
1:21.8	and safety data, but really kind of dive into the behind-the-scenes stories of like how this
1:27.4	whole approval process was not the traditional way FDA normally approves medication.
1:33.3	So let's dive right into it.
1:35.5	Awesome.
1:36.0	Well, Dr. Patel, I think it's probably worth just mentioning a little bit about the background of Alzheimer's disease.
1:41.0	And that's what Adiolm is FDA indicated for at this point. Alzheimer's disease is a that's what Adjahelma's FDA indicated for at this point.
1:45.2	Alzheimer's disease is a neurodegenerative disease. It's the actually main cause of cognitive
1:50.1	impairment and dementia in older adults. And the pathophysiology is complex, but one of the essential
1:57.3	features is these plaques, these amyloid beta plaques, these peptides that form in the brain.
	...

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