Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

FDA review of Alzheimer’s drugs

Executive Summary

Approximately 60 percent of new drug applications for Alzheimer's therapies are approved by FDA in the first cycle, compared to 96 percent for HIV/AIDS drugs and 94 percent for selected cancer therapies, according to a report by Avalere Health. The consulting firm evaluated review times for five Alzheimer's therapies, 26 HIV/AIDS drugs, and 18 cancer treatments. "We found that the FDA met PDUFA review timelines for all drug categories; there was no evidence of a slower or delayed FDA review time for Alzheimer's," Avalere reports. However, HIV/AIDS and cancer drugs were more successful than Alzheimer's drugs at obtaining priority review and approval in the first cycle. The study was sponsored by Wyeth, which has 11 candidates under development to treat Alzheimer's disease, including bapinezumab, slated to enter Phase III in the second half of the year. Bapinezumab, codeveloped by Elan, has been granted fast track designation by FDA...

You may also be interested in...



Rethinking Alzheimer's: Mapping Out an Approval Process

Drug companies involved in Alzheimer's disease research are a little fed up with FDA. Some, like Wyeth, believe the agency should put Alzheimer's research higher up on its priority list and allow the use of surrogate endpoints for clinical trials. But FDA says that no validated surrogate exists for Alzheimer's, and until it has hard data from products in development, it is loath to recommend one. A recent reorganization of the agency's neurology group may provide an opening to press home those arguments.

The ICER Process: Allergan Engagement Improves Cost Effectiveness Rating For Ubrelvy

ICER president Steve Pearson is ‘cautiously optimistic’ that net pricing for acute migraine treatments will align with benefits once discounts are factored in.

US FDA’s 2020 Approvals: A Deep Pipeline, And More Of The Expected

Almost 50 novel agents are already under review at FDA for potential 2020 approval. Candidates are notably diverse, with concentrations in established strongholds (oncology, neuroscience), popular programs (breakthrough), and powerhouse sponsors (keep an eye on Bristol-Myers Squibb right out of the gate).

UsernamePublicRestriction

Register

PS048448

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel