FDA Approves First Treatment Option for Patients With SSc-ILD

Ofev (nintedanib) capsules have been approved by the US Food and Drug Administration for adults with interstitial lung disease associated with systemic sclerosis or scleroderma (SSc-ILD).

Nintedanib was approved in 2014 for the treatment of idiopathic pulmonary fibrosis.

This latest approval comes after a randomized, double-blind, placebo-controlled trial of 576 patients aged 20 to 79 years who had SSc-ILD showed positive results after 52 weeks of treatment. Patients taking nintedanib had improved forced vital capacity compared with their counterparts taking placebo.

Pneumonia was the most frequently reported adverse event to nintedanib.

“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,” said 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.

“Nintedanib is now a treatment option to slow the rate of decline in pulmonary function in patients who have interstitial lung disease from scleroderma.”

—Amanda Balbi

Reference:

FDA approves first treatment for patients with rare type of lung disease [press release]. Silver Spring, MD: US Food and Drug Administration; September 6, 2019. https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-patients-rare-type-lung-disease. Accessed September 9, 2019.