Aducanumab Submitted in Japan, but Decision Unlikely to Come Until Next Autumn

To read the full story

• Sign In
• Subscribe

Related Article

• CMS Decision De-Facto Denial of All Medicare Patient Access to Aduhelm: Biogen
  April 11, 2022

• Aduhelm Deal Revised, Eisai Poised to Sharpen Focus on Lecanemab: CEO
  March 17, 2022

• Biogen/Eisai Alzheimer’s Pact Amended to Switch Aducanumab Collab to Royalty Scheme
  March 16, 2022

• Eisai Formally Opposes CMS Coverage Proposal for Aduhelm
  February 14, 2022

• Eisai “Strongly Opposes” Medicare Coverage Proposal for Aduhelm, Calls for Revisit
  January 14, 2022

• Japan Seeks Additional Study for Aducanumab, Next Review Might Be Few Years Off
  December 23, 2021

• Biogen Halves US Price Tag on Aduhelm to Improve Patient Access
  December 21, 2021

• Biogen to Challenge European Rejection of Aducanumab
  December 20, 2021

• Aducanumab Gets “Negative Trend Vote” in Europe: Biogen/Eisai
  November 18, 2021

• FDA Updates Aduhelm Label to Only Cover MCI, Mild Alzheimer’s
  July 9, 2021

• Eisai CEO Says Aducanumab Price Tag Reflects Its Value, 1 Million Patients Estimated in Japan
  June 10, 2021

• Aducanumab Gets Accelerated OK, Expert Says FDA Verdict Would Affect Japan Review Too
  June 9, 2021

• FDA Approves Aducanumab, 1st Disease-Modifying Therapy for Alzheimer’s
  June 8, 2021

• FDA Delays Decision for Biogen’s Aducanumab to June 7
  February 1, 2021

• Potential Reimbursement Challenges of Aducanumab Could Usher in Health Insurance Overhaul in Japan
  January 8, 2021

• Biogen Files Japan NDA for Aducanumab
  December 10, 2020

• Expert Panel Delivers Harsh Verdict on Aducanumab, FDA Decision Due by March 7
  November 9, 2020

• European Regulators Accept Aducanumab for Review: Biogen/Eisai
  November 2, 2020

• Aducanumab Filed in Europe: Biogen/Eisai
  October 22, 2020

• Aducanumab Accepted for FDA Review with Priority Tag; Target Date Set for March 7
  August 11, 2020

• Aducanumab Filing Completed in US; Talks with Japan/EU Regulators Ongoing
  July 9, 2020

• Biogen Delays US Aducanumab Filing to Q3, but Keeps Japan’s 2020 Plan Intact
  April 24, 2020

• Biogen Eyes 2020 Aducanumab Filing in Japan Too, Nailing Down Re-Dosing Study Details
  December 19, 2019

• Eisai CEO Says Aducanumab Resurrection Was a Surprise, Touts Totality of Data as He Relays New Findings
  October 31, 2019

• In Shocking U-Turn, Biogen/Eisai Say to File Aducanumab in Early Next Year
  October 23, 2019

• Biogen to Leverage Aducanumab Learnings, Spinraza to Remain Foundation of SMA Care: Japan Chief
  June 3, 2019

• Aducanumab Termination Was Wrenching Decision: Eisai CEO
  April 24, 2019

• Biogen/Eisai’s Aducanumab Fails, Dashing Hopes in Alzheimer’s Field
  March 22, 2019