1. Scrip
  2. >>Therapy Areas
  3. >>Cardiovascular

Novartis' Inclisiran Grounded In The US By FDA Inspection Restrictions

 
• By Jessica Merrill

The US FDA issued a complete response letter for inclisiran, delaying the launch of the RNAi-based PCSK9 inhibitor for high cholesterol.

Storm at the airport. View of the airplane through rain drops.
FDA issued a CRL for Novartis' inclisiran • Source: Shutterstock

The US launch of Novartis AG' blockbuster hopeful inclisiran has been hung up by COVID-19-related manufacturing inspection delays by the Food and Drug Administration. Inclisiran is one of several potential new drug approvals that have been delayed at the FDA this year because agency officials are unable to inspect facilities due to COVID-19 safety protocols and travel restrictions.

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
Start Free Trial

Already a subscriber?

More from Cardiovascular

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

 
• By Alaric DeArment

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

 
• By Alaric DeArment

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 Andy Smith

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

 
• By Alaric DeArment

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

Seven Up For Sanofi and Regeneron With Dupixent CSU Approval

 
• By Kevin Grogan

The IL-4/IL-13 inhibitor has been approved in the US as the first targeted therapy in over a decade for chronic itching.

Lilly Scores With Orforglipron In Diabetes, Generating Excitement For Obesity

 
• By Alaric DeArment

The company announced positive topline results for the oral GLP-1 drug in type 2 diabetes that beat expectations.

In Brief: BriaCell’s Breast Cancer Cell Therapy Boosts Survival In Phase II

 
• By Sushmita Panda

BriaCell announced its cell therapy Bria-IMT plus checkpoint inhibitors bested Gilead’s Trodelvy in a Phase II trial in HR+ breast cancer; a Phase III trial is enrolling.