Can Cholesterol Drug Sponsors Make The Case For Statin Intolerance?

Amgen's FOURIER outcomes study of Repatha supports LDL-lowering in high risk patients, but price may have to come down dramatically to spur wide use of the PCSK9 inhibitors with the subjective condition of statin intolerance.

Cholesterol plaque in artery

The possibility of treating patients who cannot tolerate statins has long been eyed as a valuable segment of the cholesterol market, but has been a difficult claim to get past regulators. However, recent developments arguably may help build a market for what has been a hard-to-define population.

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 Cardiovascular

US FDA Expands Label For BMS’s Camzyos Days After Phase III Stumble

 

The agency loosened requirements for echocardiograms and removed contraindications for a number of commonly used drugs.

Camzyos nHCM Failure Could Open Door To Threat From Cytokinetics’ Aficamten

 

BMS’s Phase III ODYSSEY-HCM study did not show statistical significance for either of its two primary endpoints.

Stock Watch: Disappointing ACC Share Price Reactions For AstraZeneca And Lilly

 
• By 

The end of the American College of Cardiology conference was a prelude to a volatile trading week for most stocks. Even before Liberation Day, reactions to the conference announcements were not encouraging.

Verve Moves Toward Lilly Opt-In For PCSK9 Program With Phase Ib Results

 

The company posted positive initial results from the Heart-2 trial in HeFH and CAD, with strong LDL cholesterol lowering and a clean safety profile.

More from Therapy Areas

MetaVia’s ‘Safe’ Obesity Drug Resonates With Analysts, But Not Investors

 
• By 

The biotech reported Phase I multiple-ascending dose data for its obesity drug for the second time in a week, but its safety and tolerability do not offset concerns about relatively unimpressive weight reduction.

In Brief: US FDA Rejects Regeneron’s Bid to Extend Eylea HD Dosing

 

Regeneron is disappointed by the knock-back for longer dosing intervals for its high-dose version of Eylea, but its supplemental application for a more commercially important shorter four-week regimen has received a priority review.

Gilead Set To Expand Trodelvy/Keytruda Into Frontline TNBC

 

The company reported positive topline results for ASCENT-04, which also bode well for the ASCENT-03 trial in patients with low PD-L1 expression.