The European Medicines Agency (EMA) is reconsidering its initial rejection of lecanemab, a drug for Alzheimer's disease, following a request from Eisai, the drug's developer. Lecanemab, marketed as Leqembi, has demonstrated the ability to slow cognitive decline in early Alzheimer's and has already been approved in the United States, the United Kingdom and other countries.
EMA's Initial Concerns and Re-examination
The EMA's Committee for Medicinal Products for Human Use (CHMP) initially rejected lecanemab due to concerns that its benefits did not outweigh the risks of serious adverse events, particularly the potential for brain swelling and bleeding. However, Eisai has sought a re-examination of this decision, aiming to make the treatment available in the European Union.
"We remain focused on making a meaningful difference to those living with early AD and those closest to them. Eisai is committed to working with the CHMP and other relevant authorities with the aim of making the treatment available in the EU," said Gary Hendler, Eisai EMEA Regional Chairman and CEO.
Clinical Evidence and Unmet Needs
Eisai's phase 3 Clarity AD clinical trial demonstrated that lecanemab met its primary endpoint and all key secondary endpoints with statistically significant results. There remains a significant unmet need for new innovative treatment options that target an underlying cause of the disease’s progression.
Perspectives on the EMA's Decision
Some experts have expressed concern over the EMA's initial decision. Dr. David C. Weisman, a neurologist, argues that with proper monitoring, potential brain swelling can be detected early and managed. He also suggests that the decision may be influenced by the stigma associated with Alzheimer's disease and concerns about the cost of widespread treatment.
"The EU to not even accept reality is just totally wrong. That is anti-science, anti-medicine, and anti-health," Weisman said.
Concerns About Access and Equity
Following the approval of lecanemab in the UK, Alzheimer's Disease International CEO Paola Barbarino highlighted the importance of the EMA in ensuring the safety and efficacy of medicines in Europe. However, she also raised concerns that the EMA's negative opinion could lead to inequities, potentially driving wealthier Europeans to seek treatment in the UK.
"We are now seeing a real risk driving wealthy Europeans abroad to the UK to seek treatment, leading to huge inequities and a move towards a society where access to medications depends on income rather than need," Barbarino said.
Alzheimer Europe also expressed disappointment with the EMA’s negative opinion, hoping the agency would authorize the medicine with a clear risk management plan to address potential side effects, rather than excluding all patients from this new treatment.
