news

Breakthrough Therapy Designation granted to treatment for IDLs

2
SHARES

Ofev, which is under review for the treatment of people with chronic fibrosing interstitial lung diseases (ILDs), has been given Breakthrough Therapy Designation.

Breakthrough Therapy Designation has been granted to Ofev (nintedanib), which is currently under US Food and Drug Administration (FDA) review for the treatment of people with chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype.

 

Reserve your FREE place

 


Explore innovative, purpose-built AI solutions that elevate compliance and efficiency in quality and manufacturing operations.

17 September 2025 | 10:00 AM BST | FREE Webinar

In this webinar, find out how AI tools such as customised large language models (LLMs), orchestrated services, and human-in-the-loop design can streamline processes, enhance training, and improve efficiencies.

Don’t miss your chance to learn from industry experts – Register Now – It’s Free!

 

Boehringer Ingelheim (BI) has said this designation was supported by results from the Phase III INBUILD® study – the first clinical trial of these ILDs that met its primary endpoint and showed nintedanib slowed the rate of ILD progression in patients with a broad range of progressive fibrosing interstitial lung diseases other than idiopathic pulmonary fibrosis (IPF).

“We believe Ofev may help address an unmet medical need by providing a therapy for patients across a spectrum of ILDs with a progressive phenotype,” said Thomas Seck, MD, Senior Vice President, Medicine and Regulatory Affairs, Boehringer Ingelheim Pharmaceuticals, Inc. “We are encouraged by this Breakthrough Therapy Designation and look forward to working closely with the agency to offer this therapy to patients for which there are no FDA-approved treatment options.”

In July 2014, the FDA granted nintedanib Breakthrough Therapy Designation for the treatment of people with idiopathic pulmonary fibrosis (IPF) and approved the drug for that use in October 2014.

The efficacy and safety of nintedanib in the treatment of these ILDs has not been established. However, one of the expectations of investigational therapies that have Breakthrough Therapy Designation is that sponsors initiate a programme to make the investigational therapy available to appropriate patients through a compassionate use program. 

Regulatory applications have also been submitted to other regulatory bodies, including the European Medicines Agency (EMA).

Share via
Share via