Eisai, Biogen (BIIB) Alzheimer drug granted FDA accelerated approval

RBC Capital on Biogen (BIIB): 'FDA Summary Review Now Available; We Believe Suggests High Amenability For Future Full Leca Approval'

January 10, 2023 9:50 AM EST

RBC Capital analyst Brian Abrahams reiterated an Outperform rating and $362.00 price target on Biogen (NASDAQ: BIIB).

The analyst comments "FDA's Summary Review of Leqembi (lecanemab) is now available, and we analyzed it in depth. Overall, given that the benefit/risk assessment appeared... More

Biogen (BIIB) to Resume Trading at 3:05 p.m.

January 6, 2023 2:45 PM EST

Biogen (NASDAQ: BIIB) to Resume Trading at 3:05 p.m.

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LEQEMBI U.S. Launch Pricing at $26,500 per Year (BIIB)

January 6, 2023 2:34 PM EST

Based on hhc (human health care) concept, our corporate philosophy, Eisai is committed to improve patients health outcomes and quality of life, simplify care delivery, increase health system efficiency and spur future investments in Alzheimer's disease (AD). We consider a holistic approach in assessing value and making decisions that may affect patient access, so that our LEQEMBI pricing approach can maximize value for all stakeholders (patients, families, caregivers, healthcare providers, payers, employees and shareholders). This approach includes clinical outcome assessments of our medicines and the benefits we deliver to patients, their families and caregivers as the "clinical value," as... More

Eisai, Biogen (BIIB) Confirm FDA Approval of LEQEMBI Under Accelerated Approval Pathway for Treatment of Alzheimer's Disease

January 6, 2023 2:31 PM EST

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, "Biogen") announced today that under the Accelerated Approval Pathway the U.S. Food and Drug Administration (FDA) has approved lecanemab-irmb (Brand Name in the U.S.: LEQEMBI) 100 mg/mL injection for intravenous use, a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble ("protofibril")* and insoluble forms of amyloid beta (A) for the treatment of Alzheimer's disease (AD). The approval is based on Phase 2 data that demonstrated that LEQEMBI reduced the accumulation of A plaque in the... More

Eisai, Biogen get U.S. FDA approval for Alzheimer's drug, apply for full approval

January 6, 2023 2:18 PM EST

By Julie Steenhuysen and Deena Beasley

(Reuters) -The U.S. Food and Drug Administration on Friday approved the Alzheimer's drug lecanemab developed by Eisai Co Ltd and Biogen Inc for patients in the earliest stages of the mind-wasting disease.

Eisai and Biogen said on Saturday the Japanese drugmaker had applied for full FDA approval of the drug.

The drug, to be sold under the brand Leqembi, belongs to a class of treatments that aim to slow the advance of the neurodegenerative disease by removing sticky clumps of the toxic protein beta amyloid from the brain.

Nearly... More