FDA nod for first treatment for certain progressive interstitial lung diseases

The US Food and Drug Administration on Monday approved Ofev (nintedanib) oral capsules to treat patients with chronic fibrosing (scarring) interstitial lung diseases (ILD) with a progressive phenotype (trait), helping to “fulfil an unmet need, as patients with these life-threatening lung diseases have not had an approved medication until now,” noted a statement from the FDA.

Marketed by family-owned German pharma major Boehringer Ingelheim, Ofev is the first FDA-approved treatment for this group of fibrosing lung diseases that worsen over time and was reviewed under a Breakthrough Therapy designation process.

Ofev is already approved in the USA and more than 75 countries for the treatment of patients living with idiopathic lung fibrosis (IPF). In September 2019, Ofev was approved in the USA as the first and only therapy to slow the rate of decline in pulmonary function in patients with SSc-ILD. The drug garnered around $747.4 million sales in the first half of this year. Boehringer has yet to report full-year 2019 financials.