es.euronews.com
EMA Blocks Alzheimer's Drug Donanemab Due to Fatal Side Effects
The European Medicines Agency (EMA) blocked Lilly's Alzheimer's drug, donanemab (Kisunla), due to potentially fatal side effects, despite its approval in the US and UK; the drug slowed Alzheimer's progression by 35% in trials but caused three deaths, two linked to a gene increasing Alzheimer's risk; the EMA deemed the risks outweighed the benefits.
- What are the immediate consequences of the EMA's decision to block donanemab, considering its approval status in other countries?
- The European Medicines Agency (EMA) blocked Lilly's Alzheimer's drug, donanemab (Kisunla), due to potentially fatal side effects, despite its approval in the US and UK. Donanemab, an intravenous antibody slowing Alzheimer's progression, showed a 35% symptom slowdown in trials but caused three deaths, two linked to a specific gene increasing Alzheimer's risk. The EMA deemed the risks outweighed the benefits.
- What are the broader implications of the EMA's decision for future Alzheimer's drug development and regulatory processes in Europe and globally?
- The EMA's rejection of donanemab, despite its approval elsewhere, reveals potential inconsistencies in global drug regulatory processes. Lilly's request for restricted use (excluding patients with the at-risk gene) was denied, suggesting a stricter approach in Europe. Future Alzheimer's drug approvals will likely face heightened scrutiny regarding safety profiles and targeted patient populations.
- What factors contributed to the EMA's assessment of the risks outweighing the benefits of donanemab, and how does this compare to other recently approved Alzheimer's drugs?
- The EMA's decision highlights the complex risk-benefit assessment in Alzheimer's drug approvals. While donanemab showed promise in slowing disease progression, the potential for fatal side effects, particularly in patients with a specific gene, led to its rejection. This underscores the need for careful evaluation of such drugs and targeted patient selection.
Cognitive Concepts
Framing Bias
The article frames the story primarily around the EMA's rejection, emphasizing the potential risks and highlighting the deaths associated with the drug's trial. While the benefits are mentioned, the overall tone and emphasis lean towards portraying the drug negatively. The headline itself focuses on the blocking of the drug, setting a negative tone from the start. This framing might unduly alarm readers and overshadow the potential benefits for suitable candidates.
Language Bias
The language used is generally neutral, although words like "mortales" (mortal) and "riesgos" (risks) are used repeatedly, creating a sense of urgency and danger. Phrases such as "implicable y mortal" (unforgiving and deadly) further intensify the negative portrayal of the disease and the drug's potential side effects. The use of 'blocked' in the headline is quite strong, implying a negative action rather than a cautious decision.
Bias by Omission
The article focuses heavily on the EMA's rejection and potential risks of the drug, but omits discussion of the perspectives of those who might benefit from the drug despite the risks. It mentions patient enthusiasm but doesn't delve into the details of their arguments or the potential benefits outweighing the risks for specific patient groups. There is also no mention of the cost-effectiveness analysis done by the UK's NHS which led to the drug not being offered to patients there, beyond a brief mention at the end.
False Dichotomy
The article presents a false dichotomy by framing the situation as either complete approval or complete rejection of the drug, ignoring the possibility of a controlled rollout to specific patient subgroups as suggested by Alzheimer Europe. The potential for mitigation of risks through careful patient selection is not fully explored.
Sustainable Development Goals
The European Medicines Agency (EMA) blocked the Alzheimer's drug Donanemab due to potentially fatal side effects, hindering progress toward improving health and well-being for Alzheimer's patients in Europe. While the drug showed promise in slowing disease progression, the EMA deemed the risks outweighed the benefits. This decision impacts access to potentially life-improving medication for millions of Alzheimer's patients across Europe.