Ofev Tagged a Breakthrough Therapy After Positive Ph3 Results

The FDA has granted Ofev (nintedanib) a breakthrough therapy designation for chronic fibrosing interstitial lung disease, according to Boehringer Ingelheim, Healio.com reported.
The approval was based on data from Boehringer Ingelheim’s Phase III INBUILD trial, which showed Ofev slowed lung function decline by 57% in patients with chronic fibrosing interstitial lung disease (ILDs) with signs of progression.¹

According to Boehringer, the study met its primary endpoint and demonstrated the efficacy and safety of Ofev in patients with a broad range of progressive fibrosing interstitial lung diseases other than idiopathic pulmonary fibrosis (IPF).¹

“Patients suffering from different ILDs have variable, often irreversible damage to their lungs with a poor prognosis. Unfortunately, to date there are no medications approved for the treatment of progressive fibrosing ILDs, except for IPF,” explained Dr. Martin Kolb, Director, Division of Respirology, Department of Medicine, McMaster University. “The recent results of the INBUILD trial identified conclusively that OFEV slowed the decline of pulmonary function in patients who suffer from progressive pulmonary fibrosis, across the ILD spectrum.”

Chronic hypersensitivity pneumonitis, autoimmune ILDs such as rheumatoid arthritis-associated ILD, systemic sclerosis-associated ILD (SSc-ILD), mixed connective tissue disease-associated ILD, sarcoidosis and idiopathic forms of interstitial pneumonias, ie non-specific interstitial pneumonia, and unclassified idiopathic interstitial pneumonia, are among these diseases. Nintedanib was shown to slow the rate of ILD progression independent of the fibrotic pattern seen on chest imaging.¹ The side effect profile was consistent with previous studies of nintedanib in ILDs, with diarrhea being the most common adverse event.¹

“We are very proud to be presenting the results of this first ever clinical trial studying patients with different forms of progressive fibrosing ILDs, which are the basis of the regulatory applications that were recently submitted with the FDA and EMA,” commented Dr. Mehdi Shahidi, M.D., Chief Medical Officer, Boehringer Ingelheim. “We are absolutely 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.”

Reference

¹ Flaherty K, et al. Nintedanib in Progressive Fibrosing Interstitial Lung Diseases N Eng J Med. Published 29 September, 2019. NEJM.org. DOI: 10.1056/NEJMoa1908681