INGELHEIM, Germany-Wednesday 15 July 2020 [ AETOS Wire ]- 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
View source version on businesswire.com: https://www.businesswire.com/news/home/20200715005540/en/
Contacts
Boehringer Ingelheim
Corporate Communications
Media + PR
Alexander Kurz
55216 Ingelheim/Germany
Tel.: +49 (6132) 77-184531
Mobile: +49 (151) 68948378
Email: press@boehringer-ingelheim.com
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