Boehringer's Ofev, Roche's Esbriet win same-day IPF approvals

The FDA played no favorites in the idiopathic pulmonary fibrosis (IPF) space – approving two new medicines on the same day on 15 October for the fatal lung disease, Boehringer Ingelheim's Ofev (nintedanib) and Roche's Esbriet (pirfenidone), despite the different timelines the drugs were on for the agency's nod.

The FDA played no favorites in the idiopathic pulmonary fibrosis (IPF) space – approving two new medicines on the same day on 15 October for the fatal lung disease, Boehringer Ingelheim's Ofev (nintedanib) and Roche's Esbriet (pirfenidone), despite the different timelines the drugs were on for the agency's nod.

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 Immunological

Disappointing Asthma Phase II Results Take Wind Out Of Sanofi’s Amlitelimab

 

Sanofi’s OX40L candidate missed a Phase II primary endpoint, but the company believes it can still work in a sub-group of ‘heterogeneous inflammatory asthma’ patients.

J&J’s Icotrokinra Scores In Important Adolescent Patient Segment

 

The company presented positive Phase III data from a subset analysis of ICONIC-LEAD comprising patients with moderate-to-severe plaque psoriasis.

Cartesian Maps Out CAR-T Strategy With Simpler Logistics In Mind

 

The company announced positive Phase IIb data for Descartes-08 in myasthenia gravis, with especially strong efficacy among patients without prior biologic treatment.

Equillium Seeks Accelerated Approval For GVHD Drug Despite Primary Endpoint Miss

 

The biotech is banking on itolizumab’s longer-term efficacy as well as unmet need in frontline acute graft-versus-host disease as it prepares to meet with the FDA.

More from Therapy Areas

Ironwood To Consider All Options With Apraglutide Setback In SBS

 
• By 

With the FDA asking for another Phase III trial, the short bowel syndrome drug apraglutide could be years away from market, while the Linzess patent expiry and near-term debt loom.

Pfizer’s Danuglipron Is Done, Sparking M&A Speculation

 

The company discontinued development of its oral GLP-1 receptor agonist for weight management due to a safety signal.

Amgen’s Imdelltra Sets The Pace In Small-Cell Lung Cancer

 

The bispecific is the first in its class to record a Phase III survival win in small-cell lung cancer, although antibody-drug conjugates and other rivals could challenge in the coming years.