BI Receives Positive Opinion from EMA Advisory Committee for IPF DrugBy
Boehringer Ingelheim reports that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for nintedanib (suggested brand name OFEV) for the treatment of patients with idiopathic pulmonary fibrosis (IPF). The opinion comes after US Food and Drug Administration (FDA) approval of nintedanib for the treatment of IPF in October 2014.
Nintedanib is a small-molecule tyrosine kinase inhibitor developed by Boehringer Ingelheim for IPF. Nintedanib*, one capsule twice a day, slows disease progression by reducing the annual rate of decline in lung function by 50% in a broad range of IPF patient types. IPF is a debilitating and fatal lung disease with a median survival of two to three years after diagnosis It causes progressive scarring of the lungs, resulting in continual and irreversible deterioration in lung function and difficulty breathing.
Nintedanib targets growth factor receptors, which have been shown to be involved in the mechanisms by which pulmonary fibrosis occurs. Nintedanib inhibits platelet-derived growth factor receptor (PDGFR), fibroblast growth factor receptor (FGFR), and vascular endothelial growth factor receptor (VEGFR). By blocking the signaling pathways that are involved in fibrotic processes, it is believed that nintedanib has the potential to reduce disease progression in IPF by slowing the decline of lung function.
Nintedanib in IPF has been granted accelerated assessment by the EMA. Nintedanib is also in clinical development as a treatment option for cancer. The CHMP 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 of adenocarcinoma tumor histology, after first-line chemotherapy.
In October 2014, Roche received FDA approval for its IPF drug, Esbriet (pirfenidone). Esbriet was developed for use by InterMune in the United States, Europe, and other countries. It 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. Roche gained the drug through its acquisition of InterMune earlier this year.
Source: Boehringer Ingelheim