The EC approval for nintedanib follows the positive opinion from the Committee for Medicinal Products for Human Use (CHMP), granted in May this year
European Commission flags. (Credit: Sébastien Bertrand/commons.wikimedia.)
Boehringer Ingelheim has received the expanded European Commission (EC) approval for nintedanib to include treatment for a type of pulmonary fibrosis.
The additional indication for nintedanib includes the treatment of other chronic fibrosing interstitial lung diseases (ILDs) in adults with a progressive phenotype beyond idiopathic pulmonary fibrosis (IPF).
The Germany-based pharmaceutical firm said that the regulatory approval follows the positive opinion from the Committee for Medicinal Products for Human Use (CHMP), granted in May 2020.
Also, the US Food and Drug Administration (FDA), Health Canada and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) have recently approved the drug as a treatment for the current indication.
Boehringer Ingelheim senior vice president and inflammation therapeutic area head 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 was available. Bringing new hope to those patients constitutes a therapeutic breakthrough.”
The expanded EC approval for nintedanib is based on results from the INBUILD study
The regulatory approval is supported by the results from INBUILD, a randomised, double-blind, placebo-controlled, parallel-group phase 3 clinical trial. The study evaluated 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 assessed over 52 weeks was the primary endpoint of the clinical trial.
In the study, patients treated with nintedanib lost only 81mL while patients on placebo lost 188mL lung volume over a year, confirming that the nintedanib slowed the lung function decline by 57% versus placebo.
In the INBUILD trial, treatment with nintedanib was consistent for all patients, regardless of the fibrotic pattern on high-resolution computed tomography (HRCT) and was also consistent with the results in nintedanib trials studying patients with IPF and SSc-ILD, said the company.
European Idiopathic Pulmonary Fibrosis and Related Disorder Federation (EU-IPFF) secretary Liam Galvin “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.
“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.”