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Sanofi/Regeneron’s PCSK9 Data Show Robust LDL Reduction, But Prompt Call For Outcomes Data

 
• By Emily Hayes

Novel inhibitor of PCSK9 lowers LDL cholesterol far beyond what can be achieved by statins. Investigators report reductions of 40% to 72% in new Phase II trial.

Based on the results and reception of a Phase II study for the PCSK9 inhibitor REGN727/SAR236553, Regeneron Pharmaceuticals Inc./Sanoficould have a “game changer” for lipid disorders on their hands, but they are also likely to face demand for outcomes data and fears about autoimmunity if they target large potential patient populations.

PCSK9, or proprotein convertase subtilisin/kexin type 9, is a protein thought to cause the destruction of LDL receptors, making it harder to clear LDL cholesterol. Genetic studies indicate that low...

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More from Clinical Trials

Canada Cuts Red Tape With Single Ethics Review For Trials Clone

 
• By Neena Brizmohun

A new research ethics review system for multi-site clinical trials in Canada is expected to help improve study start-up times, avoid unnecessary duplication and boost the country’s competitiveness on a global stage.

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.

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.

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EMA: ‘Sad To See’ Member States Against Patient Engagement Under EU Pharma Reform

 
• By Eliza Slawther

The European Medicines Agency’s chief medical officer Steffen Thistrup argued that patients are able to understand the “complex regulatory and scientific issues” that the EMA committees discuss when they assess drugs.

EU To Track Decentralized Clinical Trials In CTIS To Support Innovation

 
• By Vibha Sharma

Monitoring the use of decentralized elements in clinical trials is a priority for the European medicines regulatory network.

Pink Sheet Podcast: US FDA’s Big Vaccine Policy Week

 
• By Derrick Gingery, Sarah Karlin-Smith, Sue Sutter, and Nielsen Hobbs

Pink Sheet reporter and editors discuss the new clinical trial requirements that the FDA announced for COVID-19 vaccines, the updated label for Novavax’s newly approved COVID-19 vaccine, and other vaccine-related events that were part of a busy week for policy in the sector.