Boehringer Ingelheim announced that the European Medicines Agency (EMA) has granted accelerated review to its marketing authorization application (MAA) for nintedanib for treatment of idiopathic pulmonary fibrosis (IPF) in the EU.
Nintedanib is an investigational small molecule tyrosine kinase inhibitor (TKI) developed by Boehringer Ingelheim for the treatment of IPF. The drug reduces the disease’s progression and the loss of lung function by blocking signaling pathways involved in fibrotic processes. The drug is also being investigated as a treatment for cancer, including hepatocellular carcinoma, ovarian cancer, non-small cell lung cancer, and colorectal cancer.
The MAA for nintedanib was based on results from two Phase III trials INPULSIS-1 and INPULSIS-2, which demonstrated that the drug impeded disease progression in patients with IPF. Results from the two 52 week trials were recently published in the New England Journal of Medicine.
Idiopathic pulmonary fibrosis (IPF) is a progressive, chronic, severely debilitating and eventually lethal lung disease that affects up to 14 to 43 people per 100,000 around the world. The disease is characterized by fibrosis (scarring of lung tissue) and loss of lung function over time. Affected patients experience coughing and shortness of breath, which hampers their ability to participate in daily physical activities. As of present, patients with IPF have limited treatment options for their disease.
Professor Klaus Dugi, CMO of Boehringer Ingelheim, said, “IPF is a relentless and fatal lung disease, and there is a high unmet need for effective treatments that can slow disease progression. Acceptance of our marketing authorization application takes us one step closer to meeting this unmet need and providing a new treatment option to patients living with IPF.”
This news comes shortly after the company announced that it has successfully resolved a warning letter from the FDA concerning its manufacturing facility in Ingelheim, Germany. The FDA has determined that quality management and compliance systems of the site as acceptable after its March inspection.