Drug Discovery and Development

  • Home Drug Discovery and Development
  • Drug Discovery
  • Genomics/Proteomics
  • Oncology
  • Neurological Disease
  • Infectious Disease
  • R&D 100 Awards
  • Pharma 50
    • 2022 Pharma 50
    • 2021 Pharma 50

FDA Revises Alzheimer’s Trial Rules

By Drug Discovery Trends Editor | July 12, 2011

The government is making it easier to test new Alzheimer’s drugs, hoping to speed progress toward new treatments for the mind-robbing disease.

One of every eight people 65 or older has Alzheimer’s, the most common form of dementia. Current drugs only ease symptoms temporarily and don’t slow its advance.

Many drugs have flopped in late-stage testing in recent years, including some that seemed to clear harmful plaque from addled brains.

Last year, the Food and Drug Administration put restrictions on who could be in experiments targeting this plaque. They agency said participants had to drop out if they developed signs of bleeding in the brain.

A panel of industry, nonprofit and academic researchers thought that would choke off promising research. They gathered evidence that such bleeding and other abnormalities seen on brain scans were fairly common and might even be a sign that a drug is working as intended.

That would mean it doesn’t necessarily doom a treatment, said Dr. Reisa Sperling, director of the Center for Alzheimer Research and Treatment at Brigham and Women’s and Massachusetts General Hospitals. “It’s not clear yet whether these are a sign of damage, but they may not be as concerning as we initially thought.”

The FDA was persuaded, and adopted the panel’s findings, which are being published online Tuesday in the journal Alzheimer’s & Dementia.

The relaxed rules are a boon for companies like Pfizer Inc. and Johnson & Johnson subsidiary Janssen Alzheimer Immunotherapy, which are testing an experimental drug called bapineuzumab (bap-ih-NUZE-uh-mab) in thousands of patients now. Eli Lilly & Co. also has an Alzheimer’s drug in late-stage tests. Those companies took part in the panel that came up with the new rules.

They will be discussed next week at an international Alzheimer’s Association conference in Paris.

Date: July 12, 2011
Source: Associated Press

 


Filed Under: Drug Discovery

 

Related Articles Read More >

Takeda Pharmaceutical in the Drug Discovery & Development Pharma 50
Takeda’s Takhzyro fares well in pediatric hereditary angioedema study
Novartis in the Pharma 50
Novartis to cut up to 8,000 positions
Gilead Sciences in the Drug Discovery & Development Pharma 50
Gilead resubmits application to FDA for twice-yearly HIV drug lenacapavir
George Floyd mural
How the pandemic and George Floyd made clinical trial diversity a priority

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.

Need Drug Discovery news in a minute?

We Deliver!
Drug Discovery & Development Enewsletters get you caught up on all the mission critical news you need. Sign up today.
Enews Signup
Drug Discovery and Development
  • MASSDEVICE
  • DEVICETALKS
  • Medical Design & Outsourcing
  • MEDICAL TUBING + EXTRUSION
  • MEDTECH 100
  • Medical Design Sourcing
  • Subscribe to our Free E-Newsletter
  • Contact Us
  • About Us
  • Advertise With Us
  • R&D World
  • Drug Delivery Business News
  • Pharmaceutical Processing World

Copyright © 2022 WTWH Media LLC. All Rights Reserved. The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media
Privacy Policy | Advertising | About Us

Search Drug Discovery & Development

  • Home Drug Discovery and Development
  • Drug Discovery
  • Genomics/Proteomics
  • Oncology
  • Neurological Disease
  • Infectious Disease
  • R&D 100 Awards
  • Pharma 50
    • 2022 Pharma 50
    • 2021 Pharma 50