The approval of Aβ-clearing antibodies like Leqembi (lecanemab) and Kisunla (donanemab) marked a landmark shift toward disease-modifying therapies in Alzheimer’s,…
BUSINESS
Eisai Begins FDA Rolling Submission for Leqembi SC for Starting Dose
Eisai has begun a rolling submission to the US FDA seeking approval for the use of a subcutaneous autoinjector version of Leqembi (lecanemab) as a once-weekly dosing option beginning from the initiation phase of treatment. The filing is being made…
To read the full story
Related Article
- Leqembi Iqlik Now Available for Alzheimer’s Initiation Use in US
August 25, 2026
- FDA Greenlights Leqembi Iqlik for Alzheimer’s Initiation Therapy
July 14, 2026
- FDA Delays Review of Leqembi Iqlik for Alzheimer’s Initiation Therapy
May 11, 2026
- Leqembi Iqlik Now under FDA Review for Initiation Phase
January 26, 2026
- Rolling Submission for Leqembi SC Starting Dose Completed in US
November 27, 2025
- Leqembi Iqlik Autoinjector Now Available in US: Eisai/Biogen
October 8, 2025
- FDA Clears Leqembi Autoinjector; Launch Set for Oct. 6
September 2, 2025
- FDA Accepts Leqembi SC for Review; Target Date Set to Aug. 31
January 15, 2025
- FDA Rolling Submission for Leqembi SC Completed: Eisai
November 5, 2024
- Eisai Begins Rolling Submission for Subcutaneous Leqembi in US
May 16, 2024
BUSINESS
- Kissei Cuts H1 Profit Outlook on Tavneos Approval Revocation Risk
October 29, 2026
- Nxera Licenses Fabry Disease Drug from Idorsia
October 29, 2026
- Novo Nordisk Hints at GLP-1 Supply Restrictions to Curb Inappropriate Use
October 29, 2026
- J-TEC, Maruho to Co-Promote Jacemin from April
October 29, 2026
- KM Biologics to Supply Mpox Vaccine to WHO-Led Vaccine Stockpile
October 29, 2026
PHARMA JAPAN welcomes JETRO New York’s Shunsuke Tani as a guest columnist. In occasional contributions, Tani will share his perspectives on US pharmaceutical policy, industry developments, and life in America, drawing on his firsthand experience in the US.---Hello from New…
Japan should fundamentally overhaul its cost-effectiveness assessment (CEA) scheme while putting a hold on CEA-based price adjustments, a new ruling…
Japanese Prime Minister Sanae Takaichi said on October 14 that the government will consider the necessary measures for the FY2027…
Eli Lilly’s breast cancer drug Imulrio (imlunestrant) is finally joining Japan’s NHI price list on October 14, nearly 300 days…
Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
Japan’s Central Social Insurance Medical Council (Chuikyo) on November 5 approved the reimbursement listing for a slate of new medicines,…
The Japanese government approved a bill to amend the Pharmaceuticals and Medical Devices (PMD) Act at its Cabinet meeting on…
Japan’s health ministry doled out regulatory approvals for a throng of new medicines on December 27 including Eli Lilly’s obesity…
Japan’s all-important reimbursement policy panel on December 20 approved an outline of drug pricing reforms for FY2024, which enshrines a…