Nintedanib

Lactation Safety InformationNew Medicines ·
28786811000001101

Lactation Safety Information

for pulmonary fibrosis

for pulmonary fibrosis
-
No published evidence of safety
Low levels anticipated in milk due to high plasma protein binding
Long half-life increases risk of accumulation in breastfed infants
Monitor infant’s hepatic enzymes
4 June 2017

New Medicines

OfevSystemic sclerosis (scleroderma) associated interstitial lung disease (SSc-ILD)

Information

Ofev
Licence extension / variation
Boehringer Ingelheim
Boehringer Ingelheim

Development and Regulatory status

Launched
Launched
Launched
April 2020
Yes
Yes
Apr 20The European Commission has approved nintedanib for the treatment of systemic sclerosis-associated interstitial lung disease (SSc-ILD) in adults [11].
Feb 20Recommended for EU approval by CHMP - the additional indication is ”for the treatment of systemic sclerosis associated interstitial lung disease” [10].
Sep 19After receiving Priority review designation, U.S. FDA have approved nintedanib (Ofev) to slow the rate of decline in pulmonary function in patients with systemic sclerosis-associated interstitial lung disease [8]
Mar 19Boehringer Ingelheim has filed for regulatory approval of nintedanib in patients with systemic sclerosis associated interstitial lung disease (SSc-ILD) with the FDA and EMA [6].
Sep 18Will be filed in EU using centralised procedure [5].
Sep 16European Commission and the US FDA grant Orphan Drug Designation to nintedanib for treatment of systemic sclerosis, including the associated interstitial lung disease (SSc-ILD) [2].

Category

Anti-fibrotic kinase inhibitor
Rare disease, affecting about 200,000 people in Europe. About 90% may go on to have some lung involvement [1]
Systemic sclerosis (scleroderma) associated interstitial lung disease (SSc-ILD)
Oral

Further information

Yes
Suspended

Trial or other data

May 19Results of SENSCIS (NCT02597933; n=576) are published in the NEJM. Among patients with ILD associated with systemic sclerosis, the annual rate of decline in FVC (primary endpoint) was lower with nintedanib vs placebo (−52.4ml/year in nintedanib group vs −93.3ml/year in placebo group (difference, 41.0ml/year; 95% CI 2.9 to 79.0; P=0.04) [7].
Jan 18NCT02597933 has fully recruited; primary outcome data still expected to complete Nov 18 [4].
Dec 16PIII (NCT02597933) study is still recruiting; collection of primary outcome data expected to complete Nov 18 [3].
Dec 15PIII trial Safety and Efficacy of Nintedanib in Systemic SClerosIS (SENSCIS™) has started recruitment. This global study (NCT02597933) is investigating the efficacy and safety of nintedanib in people with systemic sclerosis (SSc) who have developed interstitial lung disease (SSc-ILD) ). In total, 520 people are expected to be enrolled in clinical trial centres worldwide. [1]

Evidence based evaluations

OfevChronic fibrosing interstitial lung diseases (PF-ILDs) with a progressive phenotype

Information

Ofev
Licence extension / variation
Boehringer Ingelheim
Boehringer Ingelheim

Development and Regulatory status

Launched
Launched
Launched
July 2020
Yes
Yes
Jul 20Licence change approved in EU [8].
May 20Recommended for EU approval by CHMP - the additional indication is "in adults for the treatment of other chronic fibrosing interstitial lung diseases with a progressive phenotype." [7]
Mar 20Mar 20: Approved in US [6].
Feb 18Has orphan drug status in EU & US
Feb 18Will be filed in EU using centralised procedure

Category

Tyrosine kinase inhibitor of platelet-derived growth factor receptor (PDGFR) α and β, fibroblast growth factor receptor (FGFR) 1-3, and VEGFR 1-3
IPF is the most common interstitial lung disease, with an estimated incidence in the UK of around 7.44 per 100,000 population. The median survival for people with IPF in the UK is approximately 2.5 years from the time of diagnosis. However, rate of disease progression varies [1].
Chronic fibrosing interstitial lung diseases (PF-ILDs) with a progressive phenotype
Oral

Further information

Yes
September 2021

Trial or other data

Oct 19PIII RCT (NCT02999178; n=663) is published; it reports annual rate of decline in forced vital capacity (FVC) was significantly lower among patients who received nintedanib vs. placebo (−80.8 ml vs. −187.8 ml; difference 107.0 ml per year, 95% CI 65.4 to 148.5, p<0.001)
Feb 18Boehringer Ingelheim initiates a PIII trial to investigate safety and efficacy of nintedanib 150mg twice daily over 52 weeks, in patients with progressive fibrosing ILD (NCT02999178). The primary endpoint is the annual rate of decline in forced vital capacity (FVC), a measure of disease progression. The randomised, double-blind, placebo-controlled trial will enrol approximately 600 patients in the US & EU (including UK)
Feb 18PIII (NCT02999178) study is due to complete collection of primary outcome data in Jul 19

Evidence based evaluations

28 July 2020EPAR