Boehringer Ingelheim, Roche Each Gain FDA Approval for Their Lung Disease Drugs
Boehringer Ingelheim and Roche have each received US Food and Drug Administration approval for their respective new molecular entities for treating idiopathic pulmonary fibrosis (IPF). Boehringer Ingelheim received FDA approval for Ofev (nintedanib), and Roche received FDA approval of Esbriet (pirfenidone).
Idiopathic pulmonary fibrosis is a condition in which the lungs become progressively scarred over time. As a result, patients with IPF experience shortness of breath, cough, and have difficulty participating in everyday physical activities. Current treatments for IPF include oxygen therapy, pulmonary rehabilitation, and lung transplant.
Ofev is a small-molecule tyrosine kinase inhibitor that blocks multiple pathways that may be involved in the scarring of lung tissue. Nintedanib targets growth factor receptors involved in the mechanisms by which pulmonary fibrosis occurs. Most importantly, nintedanib, inhibits the platelet-derived growth factor receptor (PDGFR), fibroblast growth factor receptor (FGFR), and the vascular endothelial growth factor receptor (VEGFR. The FDA granted Ofev fast track, priority review, orphan product, and breakthrough designations. Ofev is being approved ahead of the product's prescription drug user fee goal date of Jan. 2, 2015, the date the agency was scheduled to complete the review of the drug application.
Boehringer Ingelheim announced in June 2014 that the application for marketing authorization of nintedanib for the treatment of IPF has been validated and granted accelerated assessment by the European Medicines Agency (EMA). Separately, the Committee for Medicinal Products for Human Use (CHMP) of the EMA also recently issued a positive opinion for the approval of nintedanib in combination with docetaxel for the treatment of adult patients with locally advanced, metastatic or locally recurrent non-small cell lung cancer (NSCLC) of adenocarcinoma tumour histology, after first-line chemotherapy.
Esbriet also acts on multiple pathways that may be involved in the scarring of lung tissue. it is believed to interfere with the production of transforming growth factor (TGF)-beta, a small protein in the body involved in how cells grow and tumor necrosis factor (TNF)-alpha, a small protein that is involved in inflammation.
The FDA granted Esbriet fast track, priority review, orphan product, and breakthrough designations. Esbriet is being approved ahead of the product's prescription drug user fee goal date of Nov. 23, 2014, the date the agency was scheduled to complete the review of the drug application.
Esbriet was developed by InterMune, Inc., which Roche acquired in September 2014. The drug was granted marketing authorization in the European Union (EU) in 2011 for the treatment of adults with mild to moderate IPF in all 28 EU member countries and has since been approved in Norway, Iceland, and Canada.