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🏅 FDA Orphan Designation

Ofev

NINTEDANIB

Manufacturer: Boehringer Ingelheim Pharmaceuticals, Inc.

Indicated for:
Idiopathic pulmonary fibrosisOrphanExposure-related interstitial lung diseaseOrphanInterstitial lung disease-nephrotic syndrome-epidermolysis bullosa syndrome

FDA-Approved Indications (3)

Treatment of idiopathic pulmonary fibrosis

OFEV is indicated to slow the rate of decline in pulmonary function in patients with systemic sclerosis associated interstitial lung disease (SSc-ILD).

Treatment of chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype

Population: adults

Indications & Usage

1 INDICATIONS AND USAGE OFEV is a kinase inhibitor indicated in adults for: Treatment of idiopathic pulmonary fibrosis (IPF) ( 1.1 ) Treatment of chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype ( 1.2 ) Slowing the rate of decline in pulmonary function in patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD) ( 1.3 ) 1.1 Idiopathic Pulmonary Fibrosis OFEV is indicated for the treatment of adults with idiopathic pulmonary fibrosis (IPF). 1.2 Chronic Fibrosing Interstitial Lung Diseases with a Progressive Phenotype OFEV is indicated for the treatment of adults with chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype [see Clinical Studies (14.2) ] . 1.3 Systemic Sclerosis-Associated Interstitial Lung Disease OFEV is indicated to slow the rate of decline in pulmonary function in adult patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD).

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Ofev
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Medical disclaimer: This information is for educational purposes only. Always consult a qualified healthcare provider before making treatment decisions. Data sourced from FDA and current as of our last update.