EC approves new indication for Boehringer’s nintedanib in pulmonary fibrosis

Boehringer Ingelheim has secured approval for a new indication of nintedanib to treat adults with other chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype beyond idiopathic pulmonary fibrosis (IPF).

Nintedanib already secured approval from the US Food and Drug Administration (FDA), Health Canada and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) as the first treatment for the same patient population.

Nintedanib is a tyrosine kinase inhibitor designed to target crucial receptors engaged in signalling pathways, which may cause pulmonary fibrosis. It already secured approval in over 80 countries to treat patients with idiopathic pulmonary fibrosis (IPF).

The approval for new indication was based on the data from INBUILD randomised, double-blind, placebo-controlled, parallel-group phase III trial that assessed the efficacy, safety, and tolerability of nintedanib in patients with chronic fibrosing ILDs with a progressive phenotype.

The annual rate of decline in forced vital capacity (FVC) in mL, which has been evaluated over 52 weeks, is the primary endpoint of the trial.

The INBUILD trial, which was conducted at 153 sites in 15 countries, assessed the efficacy, safety, and tolerability of nintedanib (150 mg, twice daily) over 52 weeks in patients with progressive fibrosing ILD.

Boehringer randomised 663 patients in a 1:1 ratio to secure oral nintedanib (150mg twice daily) or placebo.

Boehringer Ingelheim therapeutic area inflammation head and senior vice president Peter Fang said: “We are very pleased with the European Commission’s decision to approve nintedanib as the first treatment in the EU for a group of chronic fibrosing ILDs that are progressing.

“Living with fibrotic diseases greatly impacts the lives of the affected. Various underlying diseases can lead to the development of pulmonary fibrosis and until now, no treatment option.”

In April this year, Boehringer Ingelheim secured approval from the EC for its nintedanib to treat systemic sclerosis-associated interstitial lung disease (SSc-ILD) in adult patients.