Germany and Austria have become the inaugural European Union countries to witness the launch of Leqembi, an Alzheimer’s drug developed by Eisai and Biogen after facing significant delays. Leqembi, an anti-amyloid antibody also known as lecanemab, made its debut in Austria and is set to be introduced in Germany, marking the first drug in its class to enter both markets. Approved by the European Commission in April, almost a year and a half after its marketing application submission, Leqembi overcame initial setbacks from the EMA’s human medicines committee due to concerns about its modest efficacy versus potential serious side effects.
The European Medicines Agency (EMA) changed its stance on Leqembi, granting approval with a restricted label. This label specifies that the drug is suitable for patients with a clinical diagnosis of mild cognitive impairment and mild dementia caused by Alzheimer’s disease, who possess either one or no copies of the ApoE4 genetic variant. Individuals with one or no copies of ApoE4 are at lower risk of experiencing adverse effects like brain swelling and bleeding, known as ARIA side effects, commonly associated with amyloid-targeting medications.
The launch of Leqembi in Austria and Germany is being carried out through a controlled access program, ensuring careful monitoring of patients for potential side effects by restricting the drug’s distribution and usage to a centralized registration system. Eli Lilly’s competing anti-amyloid antibody, Kisunla (donanemab), could soon join Leqembi in these markets with a similar label, following its clearance in July with restrictions on use for patients with one or no ApoE4 genes after a successful appeal against an earlier rejection.
The collaboration between Eisai and Biogen on Leqembi’s development has led to a joint effort in promoting the drug in the EU, with Eisai managing its distribution. The companies have worked closely with regional and local healthcare authorities to meet the necessary authorization requirements before the drug’s launch, ensuring a controlled access program is in place in Austria and Germany to facilitate its introduction in these initial EU countries. Despite modest sales growth since its approval in other markets such as the US, Leqembi has recently shown signs of gaining traction, with global sales in the second quarter of 2024 quadrupling compared to the same period in 2023, reaching $160 million.
Takeaways:
– Leqembi, an anti-amyloid antibody for early-stage Alzheimer’s disease, has been launched in Austria and Germany as the first drug of its class to enter the EU markets.
– The drug was approved by the European Commission with a restricted label, indicating its use for patients with mild cognitive impairment and mild dementia due to Alzheimer’s disease who have one or no copies of the ApoE4 genetic variant.
– Leqembi’s launch involves a controlled access program in Austria and Germany, ensuring careful monitoring of patients for potential side effects and restricted distribution through a centralized registration system.
– Collaboration between Eisai and Biogen has facilitated the promotion and distribution of Leqembi in the EU markets, with the drug showing promising sales growth following its recent launch.
Tags: clinical trials, biosimilars, cell therapy, cell therapies
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