Biogen and Eisai Initiate FDA Rolling Submission for Early Alzheimer's Drug

Biogen and Eisai have begun a rolling submission to the FDA for their early Alzheimer's disease drug. Biogen is a leading biotech company with a portfolio of therapeutic products, including treatments for multiple sclerosis, psoriasis, and cancer. Net sales are primarily from medicine sales, royalties, and other revenue streams such as partnership agreements.

Biogen Inc. and Eisai Co., Ltd. have initiated a rolling submission to the U.S. Food and Drug Administration (FDA) for their early Alzheimer's disease drug, LEQEMBI® IQLIK™ (lecanemab-irmb). This submission comes as part of the ongoing collaboration between the two companies to develop and commercialize innovative treatments for neurodegenerative diseases.

LEQEMBI IQLIK is a subcutaneous autoinjector containing 360 mg/1.8 mL (200 mg/mL) of lecanemab-irmb, designed to be administered in approximately 15 seconds. The drug is indicated for maintenance dosing to treat Alzheimer's disease (AD) in patients with mild cognitive impairment (MCI) or mild dementia stage of disease, collectively referred to as early AD. After 18 months of lecanemab-irmb intravenous (IV) treatment at 10 mg/kg every two weeks, patients may either continue IV infusions at 10 mg/kg once every four weeks or start the new weekly 360 mg subcutaneous injection using the LEQEMBI IQLIK autoinjector [1].

The approval of LEQEMBI IQLIK represents a significant advancement in the treatment of early AD, offering patients and care partners an at-home injection option. The drug's approval is based on the Phase 3 Clarity AD open-label extension (OLE) trial, which evaluated a range of subcutaneous doses. Data from the trial showed that transitioning to the weekly LEQEMBI IQLIK autoinjector after 18 months of IV treatment maintained clinical and biomarker benefits comparable to continued IV dosing [1].

Biogen and Eisai's collaboration underscores their commitment to developing innovative treatments for Alzheimer's disease. Biogen, a leading biotech company, has a portfolio of therapeutic products, including treatments for multiple sclerosis, psoriasis, and cancer. Eisai, a global pharmaceutical company, is known for its strong focus on neuroscience and oncology. Together, they aim to bring forward cutting-edge treatments that improve patient outcomes and address unmet medical needs.

The rolling submission to the FDA for LEQEMBI IQLIK marks an important step in the companies' efforts to expand their portfolio and contribute to the fight against Alzheimer's disease. As the drug moves through the regulatory process, investors and financial professionals will be closely monitoring its progress and potential impact on the market.

References:
[1] https://investors.biogen.com/news-releases/news-release-details/fda-approves-leqembir-iqliktm-lecanemab-irmb-subcutaneous