The United States Food and Drug Administration (FDA) has approved Ofev (nintedanib) capsules to decrease the rate of pulmonary function in adults with interstitial lung disease associated with systemic sclerosis or scleroderma, called SSc-ILD, it was reported on Friday.
The product is the first US FDA approved treatment for the rare lung condition.
The effectiveness of the product was studied in a randomised, double-blind, placebo-controlled trial of 576 patients ages 20-79 with the disease. Patients received treatment for 52 weeks, with some patients treated up to 100 weeks. The overall safety profile observed in the Ofev treatment group was consistent with the known safety profile of the therapy.
Ofev was originally approved in 2014 for adult patients with idiopathic pulmonary fibrosis (IPF), which is another interstitial lung condition.
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