dm+d

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

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 20Approved in US [6].
Feb 18Will be filed in EU using centralised procedure
Feb 18Has orphan drug status in EU & US

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

Trial or other data

May 22Subgroup analysis of PIII INBUILD RCT (NCT02999178; n=170), found nintedanib significantly improved rate of FVC decline vs placebo (-75.9mL vs -178.6mL /year, p=0.012), with no heterogeneity of results noted across different ILD diagnosis, and adverse effects were reported to be manageable for most patients [9].
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

OfevProgressive fibrosing interstitial lung disease in children and adolescents

Information

Ofev
Licence extension / variation
Boehringer Ingelheim
Boehringer Ingelheim

Development and Regulatory status

Phase III Clinical Trials
Phase III Clinical Trials
Phase III Clinical Trials

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. Given at starting doses of 50, 75, 100 or 150 mg twice daily, based on patient weight.
In adults, IPF is the most common interstitial lung disease, with an estimated incidence in the UK of around 7.44 per 100,000 population. 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]. In children, pulmonary fibrosis (PF) is a very rare condition, sparsely described in specific forms of childrens interstitial lung disease (chILD). chILD has an incidence of 1–4 per million children [2].
Progressive fibrosing interstitial lung disease in children and adolescents
Oral