FDA News

FDA approves nintedanib for systemic sclerosis-associated ILD

The FDA has approved nintedanib capsules to slow the rate of decline in pulmonary function in adults with interstitial lung disease associated with systemic sclerosis or scleroderma, according to a press release.

The decision follows an FDA advisory panel meeting during which the committee voted in favor of approval based on findings from a randomized, placebo-controlled trial of 576 adult patients aged 20 to 79 years with systemic sclerosis-associated ILD that showed patients who received treatment with nintedanib (Ofev, Boehringer Ingelheim) had less lung function decline than those who received placebo, according to the release.

Prescribing information for nintedanib includes warnings for patients with moderate or severe hepatic impairment, those with higher liver enzymes and drug-induced liver injury, and those with gastrointestinal disorders.

Nintedanib may also cause fetal harm, arterial thromboembolic events, bleeding and gastrointestinal perforation. Patients taking P-glycoprotein and CYP3A4 inhibitors should be closely monitored. Common side effects included diarrhea, nausea, abdominal pain, vomiting, liver enzyme elevation, decreased appetite, headache, weight loss and hypertension, according to the release.

“Patients suffering from scleroderma need effective therapies, and the FDA supports the efforts of drug companies that are designing and conducting the clinical trials necessary to bring treatment options to scleroderma patients,” Nikolay Nikolov, MD, associate director for rheumatology of the division of pulmonary, allergy, and rheumatology products in the FDA’s Center for Drug Evaluation and Research, said in the press release. “Nintedanib is now a treatment option to slow the rate of decline in pulmonary function in patients who have interstitial lung disease from scleroderma.”

The FDA has approved nintedanib capsules to slow the rate of decline in pulmonary function in adults with interstitial lung disease associated with systemic sclerosis or scleroderma, according to a press release.

The decision follows an FDA advisory panel meeting during which the committee voted in favor of approval based on findings from a randomized, placebo-controlled trial of 576 adult patients aged 20 to 79 years with systemic sclerosis-associated ILD that showed patients who received treatment with nintedanib (Ofev, Boehringer Ingelheim) had less lung function decline than those who received placebo, according to the release.

Prescribing information for nintedanib includes warnings for patients with moderate or severe hepatic impairment, those with higher liver enzymes and drug-induced liver injury, and those with gastrointestinal disorders.

Nintedanib may also cause fetal harm, arterial thromboembolic events, bleeding and gastrointestinal perforation. Patients taking P-glycoprotein and CYP3A4 inhibitors should be closely monitored. Common side effects included diarrhea, nausea, abdominal pain, vomiting, liver enzyme elevation, decreased appetite, headache, weight loss and hypertension, according to the release.

“Patients suffering from scleroderma need effective therapies, and the FDA supports the efforts of drug companies that are designing and conducting the clinical trials necessary to bring treatment options to scleroderma patients,” Nikolay Nikolov, MD, associate director for rheumatology of the division of pulmonary, allergy, and rheumatology products in the FDA’s Center for Drug Evaluation and Research, said in the press release. “Nintedanib is now a treatment option to slow the rate of decline in pulmonary function in patients who have interstitial lung disease from scleroderma.”