FDA approves first treatment for patients with rare type of lung disease

FDA approves first treatment for patients with rare type of lung disease

The U.S. Food and Drug Administration today approved Ofev (nintedanib) capsules to slow the rate of decline in pulmonary function in adults with interstitial lung disease associated with systemic sclerosis or scleroderma, called SSc-ILD. It is the first FDA-approved treatment for this rare lung condition.

The overall safety profile observed in the Ofev treatment group was consistent with the known safety profile of the therapy. The most frequent serious adverse event reported in patients treated with Ofev was pneumonia (2.8% Ofev vs. 0.3% placebo). Adverse reactions leading to permanent dose reductions were reported in 34% of Ofev-treated patients compared to 4% of placebo-treated patients. Diarrhea was the most frequent adverse reaction that led to permanent dose reduction in patients treated with Ofev.

The prescribing information for Ofev includes warnings for patients with moderate or severe hepatic (liver) impairment, those with elevated liver enzymes and drug-induced liver injury and patients with gastrointestinal disorders. Ofev may also cause embryo-fetal toxicity that can result in fetal harm, arterial thromboembolic events (blood clots), bleeding and gastrointestinal perforation. P-gp and CYP3A4 inhibitors may increase nintedanib exposure, and patients taking these inhibitors should be closely monitored for tolerability of Ofev. Common side effects noted with Ofev include diarrhea, nausea, abdominal pain, vomiting, liver enzyme elevation, decreased appetite, headache, weight loss and hypertension (high blood pressure).

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