The US Food and Drug Administration on Friday approved Ofev (nintedanib) capsules to slow the rate of decline in pulmonary function in adults with interstitial lung disease associated with systemic sclerosis or scleroderma, called SSc-ILD.
Ofev, from German family-owned pharma major Boehringer Ingelheim, is the first FDA-approved treatment for this rare lung condition.
It is estimated that up to 2.5 million people worldwide have scleroderma, including around 100,000 people in the USA. A filing for this indication for Ofev is still under review in Europe.
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