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.
- 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.