Eisai’s Alzheimer’s Drug Leqembi Shows Long-Term Benefits, Despite Study Limitations

Long-Term Efficacy::
Eisai's Alzheimer's drug, Leqembi, has demonstrated continued benefits in slowing disease progression over a three-year period, emphasizing the importance of prolonged treatment.

Study Design: The Clarity AD trial involved three patient cohorts::
one receiving Leqembi for the entire three years, one receiving a placebo for the first 18 months followed by Leqembi, and one receiving no treatment. The results showed that early initiation of Leqembi led to better outcomes.

Adverse Effects::
The incidence of adverse effects such as brain swelling and bleeding decreased significantly after six months of treatment, addressing concerns that had led to reservations among some medical professionals.

Regulatory Challenges::
Despite the positive data, Leqembi has faced regulatory hurdles, including a recent advisory against approval by a European regulatory body due to safety concerns and diagnostic testing requirements.

Future Developments::
Eisai and Biogen are pursuing regulatory approval for a monthly administration of Leqembi and plan to introduce an injectable version for self-administration at home, aiming to simplify treatment for patients.

Impact on Alzheimer's Management::
The findings highlight the critical need for early and ongoing treatment to sustain cognitive abilities and functionality in Alzheimer's patients, even after successful elimination of amyloid plaques.