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After Leqembi Approval, US FDA In No Rush To Declare Amyloid A Validated Surrogate Endpoint

 
• By Sue Sutter

Ability to use beta amyloid plaque reduction to support a traditional approval in Alzheimer’s, or for use with other drug classes, needs to be evaluated case-by-case based on the available data, agency says. In the HIV/AIDS space, it took FDA decades to declare a surrogate endpoint validated.

Clock in sand
US FDA likely to take its time in making a validation decision about amyloid reduction as a surrogate endpoint. • Source: Shutterstock

Despite the full approval of Eisai Co., Ltd. and Biogen, Inc.’s Leqembi (lecanemab-irmb), the US Food and Drug Administration is not rushing to declare amyloid plaque reduction as a validated surrogate for clinical benefit in Alzheimer’s disease.

The 6 July conversion from accelerated to traditional approval for lecanemab is a watershed moment in Alzheimer’s disease drug development,...

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More from Approval Standards

Generic Drugs And AI: Maximum Daily Dose Tool Could Help US FDA Be ‘At The Forefront’

 
• By Michael McCaughan

The FDA is testing a new artificial intelligence tool to help generic drug developers automate maximum daily dose calculations.

UK Approves Biogen’s Qalsody After England Revises Reimbursement Approach

 
• By Eliza Slawther

Biogen has U-turned on its original decision not to file Qalsody for marketing approval in the UK for treating certain patients with amyotrophic lateral sclerosis. The move appears to have been triggered by a change in the reimbursement pathway agreed for the product.

Danish Medicines Agency Wants Companies To Use “Better Data Format” To Submit Bioequivalence Studies

 
• By Anabel Costa-Ferreira

The Danish Medicines Agency is requesting that data from bioequivalence studies to be submitted in the CDISC format in addition to the current eCTD format. It believes the move will make it easier for the agency claims to access and analyze data and will reduce the burden for applicants.

Real-Time Release Of CRLs Is US FDA’s Goal, Agency Leaders Affirm

 
• By Michael McCaughan

The US FDA says its release of complete response letters for products subsequently approved by the agency is just a first step toward releasing rejection letters when they are issued, assuming legal issues can be resolved.

More from Pathways & Standards

Generic Drugs And AI: Maximum Daily Dose Tool Could Help US FDA Be ‘At The Forefront’

 
• By Michael McCaughan

The FDA is testing a new artificial intelligence tool to help generic drug developers automate maximum daily dose calculations.

Faster HTA Reviews & Pricing Reform Could Help Fix Canada’s Drug Access Woes

 
• By Eliza Slawther

Canadian politicians must “move quickly” to introduce policies that will speed up access to medicines, such as by broadening criteria for the temporary reimbursement of medicines, the Canadian Chamber of Commerce says.

New EU Filings

 
• By Neena Brizmohun

Arimoclomol, Zevra Therapeutics's treatment for Niemann-Pick disease Type C, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.