euronews.com
EMA Rejects Alzheimer's Drug Donanemab Due to Safety Concerns
The European Medicines Agency (EMA) rejected Eli Lilly's Alzheimer's drug, donanemab, due to concerns about deadly side effects, impacting 7 million Europeans with Alzheimer's despite its 35% efficacy in slowing dementia progression in trials; the decision contrasts with the eventual approval of a similar drug, Leqembi, and Eli Lilly plans to appeal.
- What is the immediate impact of the EMA's rejection of donanemab on Alzheimer's patients in the European Union?
- The European Medicines Agency (EMA) rejected Eli Lilly's Alzheimer's drug, donanemab (Kisunla), due to concerns about potentially fatal side effects (ARIA) outweighing the benefits. This decision impacts the approximately 7 million people in Europe with Alzheimer's, delaying access to a treatment already approved in the US, UK, Japan, and China. The EMA cited three deaths in clinical trials linked to ARIA.
- How does the EMA's decision on donanemab compare to its previous decision regarding Leqembi, and what factors influenced these decisions?
- The EMA's rejection highlights the complex risk-benefit assessment for new Alzheimer's treatments. While donanemab showed a 35% reduction in dementia symptom progression, the risk of ARIA, especially in patients with a specific gene, led to the denial. This decision contrasts with the EMA's eventual approval of Leqembi, suggesting a potential path for reconsideration based on restricted patient populations.
- What are the long-term implications of the EMA's stringent approach to approving Alzheimer's drugs, considering the high cost and complex monitoring required for these treatments?
- The EMA's decision underscores the challenges of balancing innovation with patient safety in Alzheimer's drug development. Eli Lilly's plan to restrict access to patients without the high-risk gene was deemed insufficient. Future approvals will likely hinge on more stringent safety protocols and potentially controlled access programs, impacting both accessibility and cost.
Cognitive Concepts
Framing Bias
The headline and opening sentence immediately highlight the rejection of the drug, setting a negative tone. The article prioritizes the risks and the EMA's concerns, placing more emphasis on the negative aspects. While the benefits are mentioned, the focus remains on the rejection, influencing the reader's perception towards the drug's overall value.
Language Bias
While largely neutral, the use of phrases like "potentially deadly side effects" and "relentless, fatal disease" carries negative connotations and could evoke strong emotions. The repeated emphasis on the risks might unintentionally downplay the potential benefits. More balanced language could include phrasing such as "serious side effects that require careful monitoring" and "significant challenges in treating this progressive disease.
Bias by Omission
The article focuses heavily on the EMA's rejection and potential side effects, but gives less detailed information on the drug's benefits beyond mentioning a 35% reduction in dementia symptom development in a clinical trial. While acknowledging the high cost, it doesn't delve into the potential long-term cost savings associated with delaying disease progression, nor does it explore alternative treatment options available to Alzheimer's patients in Europe. The perspectives of patients and their families are largely absent except through quotes from an advocacy group.
False Dichotomy
The article presents a somewhat simplistic eitheor scenario: either the drug is approved and benefits patients, or it's rejected due to risks. It doesn't fully explore the possibility of conditional approval with stringent monitoring, a middle ground explicitly mentioned by Alzheimer Europe.
Sustainable Development Goals
The European Medicines Agency (EMA) blocked the approval of donanemab, a new Alzheimer's drug, due to concerns about potentially fatal side effects. This decision negatively impacts the SDG target of ensuring healthy lives and promoting well-being for all at all ages, as it delays access to a potentially life-improving treatment for millions of Europeans suffering from Alzheimer's disease. The high cost of the drug also presents a barrier to access.