Ofev Granted New Indication to Treat Interstitial Lung Disease

September 6, 2019 – The U.S. FDA has approved a new indication for Ofev® (nintedanib), manufactured by Boehringer Ingelheim, to slow the rate of decline in pulmonary function in patients who have systemic-sclerosis-associated interstitial lung disease (SSc-ILD). It is the first drug to receive FDA-approval for this indication.

Systemic sclerosis (SSc), also known as scleroderma, is a rare autoimmune disorder that affects the skin and internal organs. It is characterized by the buildup of scar tissue (fibrosis) on the skin and other organs. The fibrosis occurs because of an excess production of collagen. Interstitial lung disease (ILD), caused by fibrosis in the lungs, is a common complication of scleroderma, and a leading cause of death for scleroderma patients. The fibrosis stiffens the lungs and makes it difficult for patients to breathe. It is typically an irreversible, progressive condition, with treatment often aimed at slowing ILD’s advance.

In a clinical study, Ofev slowed the loss of pulmonary function by 44% compared to placebo as measured over the course of 52 weeks. Lung function was measured by forced vital capacity (FVC), the amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible.

Recommended dosing is 150mg twice daily taken approximately 12 hours apart with food. The dose should be reduced to 100mg twice a day for patients who have mild hepatic impairment (Child Pugh A). The prescriber should test liver function and test for pregnancy (in females of reproductive potential) prior to initiating treatment.

Originally FDA approved in 2014, Ofev is also indicated to treat idiopathic pulmonary fibrosis (IPF), which is a form of ILD that has no known cause.