European Commission approves third nintedanib indication in pulmonary fibrosis1

• The approval is for the treatment of adults with other chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype beyond idiopathic pulmonary fibrosis (IPF).¹
• The decision is based on the results of the INBUILD^® trial, the first study to evaluate patients with a broad range of chronic fibrosing interstitial lung diseases (ILDs) and a progressive disease behavior.²
• Nintedanib is already approved in more than 80 countries for the treatment of idiopathic pulmonary fibrosis (IPF), and for systemic sclerosis-associated interstitial lung disease (SSc-ILD) in more than 40 countries.

(BUSINESS WIRE) -- Boehringer Ingelheim today announced that the European Commission (EC) has approved an additional indication for nintedanib in adults for the treatment of other chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype beyond idiopathic pulmonary fibrosis (IPF).¹ The approval comes after the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion in May 2020.³ The U.S. Food and Drug Administration (FDA), Health Canada and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) recently approved nintedanib as the first treatment for the same patient population.^4,5,6

Interstitial lung diseases encompass a large group of more than 200 disorders that may involve the threat of pulmonary fibrosis – an irreversible scarring of lung tissue that negatively impacts lung function.⁷ People living with fibrosing ILD can develop a progressive phenotype, leading to lung function decline, deterioration in quality of life and early mortality similar to those with IPF, the most frequent form of idiopathic interstitial pneumonias.⁸ The course of the disease and the symptoms are similar in progressive forms of chronic fibrosing ILDs regardless of the underlying ILD diagnosis, and as many as 18% to 32% of patients with non-IPF ILDs are estimated to be at risk for developing a progressive fibrosing disease behavior.^9,10

The approval is based on the results of INBUILD^®, which was a randomized, double-blind, placebo-controlled, parallel-group phase III trial, which evaluated the efficacy, safety, and tolerability of nintedanib in patients with chronic fibrosing ILDs with a progressive phenotype.² The primary endpoint was the annual rate of decline in forced vital capacity (FVC) in mL assessed over a 52-week period. Patients on placebo lost 188mL lung volume over a year, while patients on nintedanib lost 81mL. This was measured as adjusted annual rate of decline over 52 weeks and meant that nintedanib slowed the lung function decline by 57% versus placebo.² The treatment effect of nintedanib in slowing FVC decline compared with placebo seen in INBUILD^® was consistent for all patients, regardless of the fibrotic pattern on high-resolution computed tomography (HRCT) and it was also consistent with the results in nintedanib trials studying patients with IPF and SSc-ILD.^2,11,12,13

In the trial, nintedanib was associated with numerical reductions in the risk of acute exacerbation or death versus placebo.² Treatment benefit may also be accompanied by reduced worsening of patient-reported outcomes such as dyspnea and cough.¹⁴ In addition, the safety profile observed in INBUILD^® was consistent to what has been seen in patients with IPF and SSc-ILD treated with nintedanib previously.²

“Making your voice heard when living with a rare life-threatening condition can be very hard and also frightening, especially if no treatment option is available,” said Liam Galvin, Secretary of the European Idiopathic Pulmonary Fibrosis and Related Disorder Federation (EU-IPFF). “The European Commission’s decision is great news for people who are at risk of developing pulmonary fibrosis due to a progressive ILD. Pulmonary fibrosis causes irreversible decline in lung function and this new indication brings much hope to those affected and their loved ones.”

“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,” added Peter Fang, Senior Vice President and Head of Therapeutic Area Inflammation at Boehringer Ingelheim. “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 was available. Bringing new hope to those patients constitutes a therapeutic breakthrough.”

Please click on the link for ‘Notes to Editors’ and ‘References’: http://www.boehringer-ingelheim.com/press-release/ecapprovalnintedanibildpf

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