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Searching For Surrogate Endpoints Requires Teamwork

 
• By Cathy Dombrowski

Discussions between FDA and researchers during a workshop on the fatty liver conditions NAFLD/NASH clarified the status of potential surrogate endpoints for clinical trials, but indicated that much work remains to be done to ready the various options for use – and that will likely need to be a joint effort.

Collaboration among sponsors is the most likely path forward to finding surrogate endpoints that reflect clinically meaningful benefits for patients with non-alcoholic fatty liver disease (NAFLD) and its progressive form, non-alcoholic steatohepatitis (NASH), which can then lead to cirrhosis and eventually the need for a liver transplant or death.

A major impediment to therapeutic advances for NAFLD and NASH is the absence of accepted measures that show patients will benefit from treatment. With NAFLD, patients accumulate fat in the...

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More from United States

US FDA’s ‘Good Reputation’ For Science May Mean Loper Bright Not ‘Cataclysmic,’ Attorney Says

 
• By Malcolm Spicer

Bridget Dooling, a law school professor who reviewed draft regulations from the FDA and other agencies as an OMB attorney, said prior federal court decisions suggest judges typically defer to agency decisions based in science.

US FDA’s Prasad: ‘We Will Always Embrace Surrogate Endpoints’

 
• By Sarah Karlin-Smith

The new CBER director, once best known in the pharma world for criticizing accelerated approval, committed to expediting cancer drugs with surrogate endpoints.

What Information Does US FDA Need For Stealth’s Elamipretide After CRL?

 
• By Sue Sutter

The agency said it will consider knee extensor muscle strength as a potential intermediate clinical endpoint to support accelerated approval, but Stealth CEO Reenie McCarthy said announcing it via complete response letter is confusing and inefficient.

UK And US Regulators In Sync On RWD External Control Arms

 
• By Vibha Sharma

The UK regulator’s draft guideline on the use of external control arms based on real-world data reflects concepts similar to those outlined by the US Food and Drug Administration.

More from North America

Rocky Rollout Spells Trouble for Medicare Prescription Payment Plan

 
• By Lauren Flynn Kelly

Enrollment in the new Medicare Prescription Payment Plan was lower than expected in the first year and well below CMS expectations, and invoicing data indicates members are slow to pay.

US FDA Meeting Drought Ends … With A Vengeance

 
• By Michael McCaughan

The first 100 days of the Trump Administration were notable for an extraordinary decline in the number of public meetings hosted by the US Food and Drug Administration. But the schedule changed quickly.

PBM Investigation, Enforcement Action ‘Critical Priorities’ At FTC, Chair Says

 
• By Cathy Kelly

The new FTC chair addressed concerns that staffing cuts will undermine the commission’s commitment to pharmacy benefit manager oversight.