Breakthrough Therapy Designation granted to treatment for IDLs

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.

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).