FDA approves first treatment for progressive ILDs

The FDA has approved the first treatment — nintedanib oral capsules — to treat patients with chronic fibrosing interstitial lung diseases with a progressive phenotype, according to a press release from the agency.

The safety and efficacy of nintedanib (Ofev, Boehringer Ingelheim) to treat chronic fibrosing ILD with a progressive phenotype in adults was evaluated in a randomized, double-blind, placebo-controlled study of 663 adults (mean age, 66 years; 54% men). During the 52-week period, patients were assigned nintedanib 150 mg twice a day or a placebo. At the end of the study, those in the nintedanib group, as compared with the placebo group, had less lung function decline.

In terms of safety, the most common adverse effects reported with nintedanib during the trial were diarrhea, nausea, stomach pain, vomiting, liver problems, decreased appetite, headache and weight loss.

The FDA noted that nintedanib is not recommended for patients with moderate or severe hepatic impairment. Elevated liver enzymes and drug-induced liver injury and gastrointestinal disorders have occurred in patients taking nintedanib. The drug may also cause embryo-fetal toxicity that can result in fetal harm, arterial thromboembolic events, bleeding and gastrointestinal perforation, according to the release. Patients taking P-glycoprotein and CYP3A4 inhibitor drugs, including ketoconazole and erythromycin, should be closely monitored, as these treatments can increase nintedanib exposure, the agency stated.

“The FDA continues to encourage the development of therapies for patients with limited or no treatment options,” Banu Karimi-Shah, MD, acting deputy director of the division of pulmonary, allergy and rheumatology products in the FDA’s Center for Drug Evaluation and Research, said in the release. “Today’s approval helps to fulfill an unmet treatment need, as patients with these life-threatening lung diseases have not had an approved medication until now.”

Nintedanib previously received FDA approval to treat idiopathic pulmonary fibrosis and to slow the rate of decline in pulmonary function among patients with ILD associated with systemic sclerosis or scleroderma. The drug had also received priority review designation and breakthrough therapy designation.