TSX higher on employment data
TOKYO/CAMBRIDGE - Eisai Co., Ltd. and Biogen Inc. (NASDAQ:BIIB), a prominent pharmaceutical player with a market capitalization of $8.9 billion and impressive 78.6% gross profit margin, have initiated a rolling submission to the U.S. Food and Drug Administration for LEQEMBI IQLIK, a subcutaneous autoinjector version of their Alzheimer’s treatment lecanemab-irmb.
According to a press release statement issued Tuesday, the companies are seeking approval for LEQEMBI IQLIK as a weekly starting dose option for patients with early Alzheimer’s disease. If approved, it would be the first anti-amyloid treatment that could be administered at home from the beginning of treatment. InvestingPro analysis shows Eisai’s strong financial health, with revenue growth of 9.4% in the last twelve months, supporting its innovative product development initiatives.
The supplemental Biologics License Application is based on data from subcutaneous administration studies conducted as part of the Phase 3 Clarity AD open-label extension. The proposed dosing regimen would involve two 250 mg injections weekly.
Currently, LEQEMBI treatment begins with bi-weekly intravenous infusions. The FDA approved subcutaneous maintenance dosing with LEQEMBI IQLIK in August 2025, but this new application seeks to extend at-home administration to the initial treatment phase.
Each LEQEMBI IQLIK autoinjector injection takes approximately 15 seconds to administer. The subcutaneous formulation could reduce healthcare resources associated with intravenous dosing, such as infusion preparation and nurse monitoring.
LEQEMBI is indicated for patients with mild cognitive impairment or mild dementia stage of Alzheimer’s disease. The treatment targets both amyloid plaque and protofibrils, which are believed to contribute to brain injury in Alzheimer’s disease.
The medication has received approval in 48 countries and is under regulatory review in 10 others. Eisai leads the development and regulatory submissions for lecanemab globally, with both companies co-commercializing the product.
In other recent news, Eisai Co. reported strong growth in sales for its Alzheimer’s drug, Leqembi, boosting its quarterly results. The company announced that global sales for Leqembi expanded by 269% year-over-year, reaching ¥23.1 billion in the first quarter. Notably, this figure included a one-time demand of ¥5.3 billion from China, previously highlighted by partner Biogen in its earnings report. When adjusted for this special demand, the underlying sales growth for Leqembi was 84%, totaling ¥17.8 billion. Additionally, Eisai and Biogen presented data on their investigational subcutaneous autoinjector for lecanemab, showing comparable efficacy and safety to the intravenous formulation. The data, presented at the Alzheimer’s Association International Conference, indicated that the 360 mg weekly subcutaneous dose maintained clinical and biomarker benefits similar to the biweekly intravenous dosing. These developments highlight Eisai’s ongoing efforts in Alzheimer’s disease treatment advancements.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.