Helsinn's anamorelin approval chances plummet on mixed PhIII cachexia data

Switzerland's Helsinn Group has presented results from two Phase III studies of cachexia drug anamorelin, with which it is planning 2015 filings in the US and Europe. But while the drug hit one of its co-primary endpoints, its failure to hit the second makes its success questionable.

Switzerland's Helsinn Group has presented results from two Phase III studies of cachexia drug anamorelin, with which it is planning 2015 filings in the US and Europe. But while the drug hit one of its co-primary endpoints, its failure to hit the second makes its success questionable.

The 12-week studies, ROMANA 1 and ROMANA 2, evaluated the effect of anamorelin on anorexia-cachexia in patients with non-small cell...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Alimentary/Metabolic

Vedanta’s Live Bacteria Reach A Dead End In Ulcerative Colitis

 

The microbiome-based company’s trial of VE202 in ulcerative colitis has failed in Phase II, but its ongoing Phase III study in C difficile infection is more promising.

Post-GLP-1 Patients Are Significant Opportunity, But Response Sees More

 

The company will move ahead in testing RDX-002 among overweight and obese patients coming off GLP-1s, but the CEO said antipsychotic-induced weight gain could represent a multibillion-dollar market.

Direct-To-Consumer And Lower Prices Key To Novo Nordisk’s Wegovy Fightback

 

The company’s incoming CEO Mike Doustdar has promised greater agility, competitiveness and execution, but investors are yet to be convinced.

Quick Listen: Scrip’s Five Must-Know Things

 
• By 

In this week's episode: EU tariff deal leaves questions for pharma; Prasad’s CBER exit could bode well for genetic medicines; Winrevair grows but Merck & Co. plans cost cuts; Novo Nordisk selects new CEO; and a look at obesity past the GLP-1s.

More from Therapy Areas

Xenon Nears Phase III Readout For Potential Epilepsy And Depression Blockbuster

 

Leading a field of rival potassium channel modulators, azetukalner will have a pivotal epilepsy readout early next year, with Phase III trials in depression and biopolar disorder also underway.

In Brief: Bayer Commits Up To $1.3bn For Kumquat’s KRAS G12D Inhibitor

 

Deal Snapshot: Bayer will take over development of the asset once Kumquat completes a Phase Ia clinical trial, but the biotech firm may opt in to share US profits and losses.

Pfizer/Astellas’s Padcev Scores First Big Win In Bladder Cancer Study

 

The drug, combined with Merck’s Keytruda, was successful among certain chemotherapy-ineligible MIBC patients, with another Phase III readout expected by March 2026.