Boehringer Ingelheim Gets First FDA Nod for Lung Disease Treatment
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.