FDA Approves First Treatment for Group of Progressive Interstitial Lung Diseases | FDA

FDA Approves First Treatment for Group of Progressive Interstitial Lung Diseases | FDA





FDA approves first treatment for group of progressive interstitial lung diseases

The U.S. Food and Drug Administration today approved Ofev (nintedanib) oral capsules to treat patients with chronic fibrosing (scarring) interstitial lung diseases (ILD) with a progressive phenotype (trait). It is the first FDA-approved treatment for this group of fibrosing lung diseases that worsen over time. The most common side effects reported in the Ofev clinical trial were diarrhea, nausea, stomach pain, vomiting, liver problems, decreased appetite, headache and weight loss. Ofev is not recommended for patients with moderate or severe hepatic (liver) impairment. Elevated liver enzymes and drug-induced liver injury and gastrointestinal disorders have occurred among people taking Ofev. It may also cause embryo-fetal toxicity that can result in fetal harm, arterial thromboembolic events (blood clots), bleeding and gastrointestinal perforation (hole formation). P-glycoprotein and CYP3A4 inhibitor drugs, including ketoconazole and erythromycin, may increase nintedanib exposure, and patients taking these inhibitors with Ofev should be closely monitored.

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