FDA Grants Breakthrough Therapy Designation to Idiopathic Pulmonary Fibrosis Treatment


BI 1015550 could treat both pulmonary fibrosis and inflammation associated with progressive fibrosing interstitial lung diseases.

The FDA has granted Breakthrough Therapy Designation to BI 1015550 (Boehringer Ingelheim), an investigational treatment for patients with idiopathic pulmonary fibrosis (IPF).

The oral, phosphodiesterase 4B (PDE4B) inhibitor could treat both IPF and inflammation associated with progressive fibrosing interstitial lung diseases, according to Boehringer Ingelheim. The treatment is being evaluated as both a monotherapy and in combination with background antifibrotic therapies to analyze the efficacy in slowing the rate of lung function decline in patients with IPF.

The FDA action followed the results of a phase 2 randomized, double-blind, placebo-controlled trial that enrolled 147 patients with IPF. The primary endpoint of the trial is change from baseline in Forced Vital Capacity over a 12-week treatment period.

Although the full results of the study will be presented at the American Thoracic Society 2022 meeting on May 16, the Breakthrough Therapy Designation is based on data collected to date.

"The accelerated development of BI 1015550 is part of Boehringer Ingelheim's next wave of potential innovative treatments for interstitial lung diseases aimed at preserving lung function and improving the lives of patients," said Thomas Seck, MD, senior vice president, Medicine and Regulatory Affairs, Boehringer Ingelheim Pharmaceuticals, in a press release. "BI 1015550 represents the first molecule in the class of PDE4B inhibitors that is being studied for IPF and other progressive fibrosing ILDs. We have built on our heritage in pulmonary fibrosis and are acting on the breakthrough designation and clinical data with the goal that this potential novel medicine can reach patients as soon as possible."


FDA Grants BI 1015550 Breakthrough Therapy Designation for Idiopathic Pulmonary Fibrosis. Boehringer Ingelheim. News release. February 24, 2022. https://www.boehringer-ingelheim.com/human-health/lung-diseases/pulmonary-fibrosis/fda-grants-bi-1015550-breakthrough-therapy-for-IPF

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