Boehringer Ingelheim Nintedanib gets USFDA Breakthrough Therapy Designation for chronic ILDs

New Delhi: Boehringer Ingelheim announced recently that the U.S. Food and Drug Administration (USFDA) granted Breakthrough Therapy Designation to nintedanib, which is currently under USFDA review for the treatment of people with chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype. Regulatory applications have been submitted to other regulatory bodies, including the European Medicines Agency.

Nintedanib is already approved in more than 70 countries for the treatment of patients living with idiopathic pulmonary fibrosis (IPF) – a chronic and ultimately fatal disease characterised by a decline in lung function. In September 2019, nintedanib was approved in the U.S. as the first and only therapy to slow the rate of decline in pulmonary function in patients with systemic sclerosis-associated ILD. Submissions have been made to other major regulatory bodies across the globe. Boehringer Ingelheim is committed to improving the lives of people living with pulmonary fibrosis, in particular, those affected by rare diseases with a high level of unmet need.

Boehringer, in its recent press release, stated that the Breakthrough Therapy 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). The results were recently presented at the European Respiratory Society (ERS) International Congress in Madrid and published in the New England Journal of Medicine.

Interstitial lung diseases encompass a large group of more than 200 disorders that may lead to pulmonary fibrosis – an irreversible scarring of lung tissue that negatively impacts lung function.2 When a progressive phenotype is present, a life-threatening condition can result that causes difficulty breathing and a decrease in the amount of oxygen the lungs can supply to the body, measured through lung function decline.

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Commenting on the same, Thomas Seck, M.D., senior vice president, Medicine and Regulatory Affairs, Boehringer Ingelheim Pharmaceuticals, Inc. said, "We believe nintedanib may help address an unmet medical need by providing therapy for patients across a spectrum of ILDs with a progressive phenotype.”

“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, ” Seck added.

The Breakthrough Therapy Designation process was established by the USFDA to expedite the development and review of drugs for serious or life-threatening conditions where preliminary clinical evidence indicates that the therapy may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints. 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.

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