The European Medicines Agency (EMA) has reversed its stance and now recommends the approval of the Alzheimer's drug Kisunla for early-stage patients. This decision follows a previous rejection due to concerns over serious side effects. The drug, already approved by the FDA, is expected to slow disease progression by about seven months. The EU Commission will make a final decision in the coming months.
New Alzheimer's Drug Receives Positive Recommendation from EMA
New Alzheimer's Drug Receives Positive Recommendation from EMA
The European Medicines Agency (EMA) has changed its position and now recommends that the EU Commission approve the drug Kisunla for early-stage Alzheimer's disease, reports Läkartidningen.
The medication is an antibody that can partially slow the progression for patients in the early stages of the disease. However, it is said to have a modest effect, potentially delaying the disease by about seven months according to studies.
The drug was approved by the U.S. Food and Drug Administration (FDA) last year. As recently as March this year, the EMA had rejected the drug, arguing that the benefits of the treatment did not outweigh the risks of serious and potentially fatal side effects, such as brain swelling and bleeding.
Pharmaceutical company Eli Lilly then requested a re-evaluation, and the EMA has now reversed its decision.
The recommendation will now be reviewed by the EU Commission, which is expected to make a final decision in the coming months.
Alzheimer's is an incurable dementia disease affecting about 100,000 Swedes, most of whom are over 65 years old.