Nintedanib (Ofev, Boehringer Ingelheim) is now the first therapy approved for patients with interstitial lung disease associated with systemic sclerosis.
Officials with the FDA today approved nintedanib (Ofev, Boehringer Ingelheim), the first treatment indicated for patients with interstitial lung disease associated with systemic sclerosis, or scleroderma, (SSc-ILD), according to a press release.
Nintendanib was initially approved in October 2014 for idiopathic pulmonary fibrosis, which is another interstitial lung condition.
With this indication, nintendanib capsules can be used to slow the rate of decline in pulmonary function among adults with SSc-ILD, a rare lung condition that is a common manifestation of scleroderma, which is a rare disease that causes tissue throughout the body, including the lungs and other organs, to thicken and scar. Approximately 25% of patients develop significant pulmonary involvement within 3 years of an ILD diagnosis, according to Boehringer.
The approval is based on efficacy data from the SENSCIS clinical study, which included 576 patients aged 20 to 79 years with SSc-ILD. For the study, patients received treatment for 52 weeks, with some treated up to 100 weeks.
At the end of the 52 weeks, patients receiving nintedanib had an adjusted annual rate of decline in forced vital capacity (FVC) (mL/year) of -52.4 mL versus -93.3 mL with a placebo. This corresponds to a 44% reduction in the rate of lung function decline, according to the results.
The study demonstrated a similar percentage of total adverse events between both groups; however, a higher incidence of diarrhea was reported in the nintedanib group (75.7%) than the placebo group (31.6%). Overall, the safety profile of nintedanib that was observed in the trial was consistent with the drug’s known safety profile.
“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 a statement. “Nintedanib is now a treatment option to slow the rate of decline in pulmonary function in patients who have interstitial lung disease from scleroderma.”
FDA approves first treatment for patients with rare type of lung disease [news release]. FDA. https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-patients-rare-type-lung-disease. Accessed September 6, 2019.
FDA Advisory Committee Recommends Approval of Ofev for the Treatment of Systemic Sclerosis Associated ILD [news release]. Boehringer Ingelheim. https://www.boehringer-ingelheim.us/press-release/fda-advisory-committee-recommends-approval-ofev-treatment-systemic-sclerosis?. Accessed September 6, 2019.