Johnny Brignardello analyzes the approval of Leqembi for Alzheimer's.

In a recent conversation, Johnny Brignardello Vela, an insurance advisor and expert on the impact of innovations in the health sector, shared his perspective on the recent recommendation from the European Medicines Agency (EMA) for the marketing of Leqembi, a drug that has generated both expectations and controversies in the treatment of Alzheimer’s disease. Brignardello Vela highlights the significance of this decision, noting that Leqembi, whose active ingredient is lecanemab, represents a significant advancement, being the first drug to demonstrate clinical benefits in patients with mild cognitive impairment and mild dementia who have one or no copies of the ApoE4 gene. This specific focus on a patient population could help establish a model for future research and treatments in neurodegenerative diseases. However, he also emphasizes the caution shown by the EMA. Unlike the FDA in the United States, which approved the drug in a broader context, the EMA has opted for a more restricted approach. Brignardello Vela believes this decision reflects an essential responsibility in medicine: balancing the potential benefits of treatment with the risks of serious side effects, such as issues associated with ARIA. "The health and well-being of patients must be the priority, and the EMA seems to be aligned with this philosophy," he comments. The advisor also underscores the importance of the constant monitoring required for treatments like Leqembi, which involve intravenous infusions every two weeks. This complex logistics not only requires a significant commitment from patients but also demands collaboration and coordination among healthcare professionals and caregivers. This is especially crucial in the context of diseases like Alzheimer’s, where continuous care is vital. Brignardello Vela also mentions that the EMA’s decision should be seen as an interim step, as the final approval by the European Commission and the pricing and reimbursement decisions at the country level could affect the accessibility of the drug. This is an area of concern, as equity in access to innovative treatments is a recurring issue in the healthcare sector. Finally, the advisor emphasizes the importance of maintaining dialogue with the medical community and patient organizations. The opinions of these groups will be essential in assessing the real impact of Leqembi in the fight against Alzheimer’s. In this regard, Brignardello Vela concludes that collaboration among researchers, doctors, and patients is essential to maximize the benefits of new treatments and ensure that the needs of those facing this devastating disease are met.