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Two Treatments For IPF Edge Closer To Market, Will Come Down To Subtle Differences

 
• By Jessica Merrill

InterMune’s pirfenidone and Boehringer Ingelheim’s nintedanib are neck-and-neck in the race to be the first drug interventions in the U.S. for the fatal lung disease. Phase III data from both drugs were presented at the American Thoracic Society meeting and published in the NEJM May 18.

Patients with idiopathic pulmonary fibrosis could soon have two new treatments on the market, notable because there are currently no drugs approved in the U.S. for the progressive and deadly lung disease. Now that both drugs have crossed the Phase III clinical trial hurdle with positive data and appear closer to FDA approval, the question has shifted to which of the two drugs – InterMune Inc.’s pirfenidone or Boehringer Ingelheim GMBH’s nintedanib – will become the standard of care for first-line treatment.

Some analysts and key opinion leaders think InterMune’s product, which is already approved in Europe and Canada as Esbriet, could...

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More from Clinical Trials

HHS Wants Employees (And Public?) To Report Diversity, Equity And Inclusion Discrimination

 
• By Sue Sutter

A survey asks FDA staff to disclose whether DEI policies caused discrimination or resulted in disciplinary action against career employees over the past five years, but uses a web form that the general public also can access.

Bayesian Statistics In EU Clinical Trials: EMA Discusses Balancing Efficiency With Rigor

 
• By Eliza Slawther

Bayesian statistics could help clinical trial sponsors to include external information in their analyses, but concerns around bias and incorrect conclusions remain, the European Medicines Agency said.

Adaptive Clinical Trials Require ‘Clear And Compelling Justification’

 
• By Vibha Sharma

A draft international guideline on using adaptive trial designs says sponsors should provide a clear rationale for using such designs to address the potential ‘tension’ between the confirmatory nature of late-stage trials and the flexibility introduced by mid-trial adaptations.

Denmark Sets New EU Benchmark With 14-Day Clinical Trial Review Timeline

 
• By Vibha Sharma

Denmark is shaking up clinical trial timelines with a new process for reviewing applications for early-phase mono-national trials that is twice as fast as the standard timelines in the EU and the UK.

More from R&D

Adaptive Clinical Trials Require ‘Clear And Compelling Justification’

 
• By Vibha Sharma

A draft international guideline on using adaptive trial designs says sponsors should provide a clear rationale for using such designs to address the potential ‘tension’ between the confirmatory nature of late-stage trials and the flexibility introduced by mid-trial adaptations.

Denmark Sets New EU Benchmark With 14-Day Clinical Trial Review Timeline

 
• By Vibha Sharma

Denmark is shaking up clinical trial timelines with a new process for reviewing applications for early-phase mono-national trials that is twice as fast as the standard timelines in the EU and the UK.

Clinical Trial Diversity Action Plan Guidance Must Return To US FDA Website, Court Says

 
• By Sue Sutter

HHS and its agencies violated the law by swiftly implementing “sweeping and poorly thought-through directives that ordered the bulk removal of healthcare resources,” including FDA draft guidances on diversity action plans and sex differences in clinical trials, a federal court said.