Boehringer Ingelheim received FDA approval for Ofev (nintedanib), making it the first drug approved for treating adult patients with systemic sclerosis or scleroderma (SSc-ILD).
Ofev is an oral capsule that slows the rate of decline in adults with SSc-ILD. It is currently approved to treat patients with idiopathic pulmonary fibrosis.
The FDA granted the new approval based on the results of a randomized trial in 576 SSc-ILD patients. The results showed that the patients treated with Ofev had less loss of lung function compared to those taking placebos.