Updated International Guidelines Recommend OFEV (Nintedanib) for IPF Treatment

Patrícia Silva, PhD avatar

by Patrícia Silva, PhD |

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Boehringer Ingelheim recently announced that it welcomes the international evidence-based 2015 ATS/ERS/JRS/ALAT Clinical Practice Guideline: Treatment of Idiopathic Pulmonary Fibrosis – An Update of the 2011 Guideline, as it suggests the use of OFEV (nintedanib) in patients with idiopathic pulmonary fibrosis (IPF). This recommendation directed to clinicians is considered conditional, meaning that healthcare providers should always debate the treatment options with the patient so that a decision can be made in line with the patient’s values and preferences.

IPF has no cure and it is estimated to affect almost 130,000 individuals in the United States and 5 million worldwide. It is a progressive fatal lung disease of unknown origin in which the alveoli and the lung tissue suffer permanent scarring (fibrosis), leading to severe breathing difficulties and compromising oxygen transfer between the lungs and the bloodstream. Patients experience a shortness of breath that gradually worsens, with respiratory failure being the main cause of death associated with IPF. The disease has a poor prognosis and around two-thirds of the patients die within five years after being diagnosed. An early diagnosis and proper treatment are crucial.

OFEV (nintedanib) is a tyrosine-kinase inhibitor that targets growth factors, like the vascular endothelial growth factor receptor (VEGFR), which have been shown to be potentially involved in IPF pathogenesis. OFEV capsules have been approved by the U.S. Food and Drug Administration (FDA) for the treatment of IPF on October 15, 2014. This approval was based on Phase II (NCT00514683) and Phase III (NCT01335464 and NCT01335477) clinical trial data involving more than 1,400 patients where OFEV (150 mg twice daily) was compared to a placebo drug for a period of 52 weeks.

“These guidelines, which update the 2011 iteration, focus on evaluation of clinical trial data in an effort to give healthcare providers an evidence-based set of recommendations for the treatment of IPF,” explained the Director of the Interstitial Lung Disease Program at The University of Chicago, Dr. Imre Noth in a press release. “Our priority is to provide quality care for patients living with this devastating disease. These new guidelines help to outline the role of OFEV in the treatment of IPF.”

The ATS/ERS/JRS/ALAT committee that issues the guidelines comprises representatives from leading societies in the respiratory field, namely the American Thoracic Society (ATS), European Respiratory Society (ERS), Japanese Respiratory Society (JRS) and Latin American Thoracic Association (ALAT). The committee continuously analyzes new data and clinical evidence regarding IPF treatment, costs and adverse effects updating the guidelines accordingly.

The recent updated recommendations emphasize the potential clinical benefit of OFEV on health outcomes that are important for the patient, such as disease progression and mortality.

“Until last year, treatment options for patients with IPF were limited. These updated international guidelines mark an important milestone in the care of IPF patients, and we’re very pleased that OFEV is included as a recommended treatment option for this devastating disease,”