Recommended in patients with PPF who have failed standard management for fibrotic ILD, other than IPF2

OFEV Is Making Progress
Against Progression

With consistent results across 5 clinical trials, OFEV (nintedanib)
is advancing the management of fibrosing ILDs.
Scroll to learn more about the clinical data, mechanism of action,
and worldwide experience of OFEV3-7

FOLLOW the PATH.
SCROLL TO SEE OUR PROGRESS

*This is a conditional recommendation. This means that different choices will be appropriate for each patient based on individual preferences. Each patient should be helped to arrive at a management decision consistent with his or her values and preferences.1,2

ALAT, Latin American Thoracic Association; ATS, American Thoracic Society; ERS, European Respiratory Society; ILD, interstitial lung disease; JRS, Japanese Respiratory Society; PPF, progressive pulmonary fibrosis.

Proven Mechanism of Action

Nintedanib is a multi-targeted tyrosine kinase inhibitor that inhibits key pathways involved in the pathogenesis of ILDs3,8,9

See how common pathogenic pathways to pulmonary fibrosis are shared among different ILDs and how nintedanib works to inhibit key pathways involved in lung fibrosis.3,9-12

MOA data are based on in vitro/in vivo data and clinical significance has not been established.

OFEV can benefit adults with fibrosing
ILDs from different etiologies3,6

INDICATION
IPF

OFEV (nintedanib) was first approved for the treatment of IPF—the prototypical chronic fibrosing ILD3,13

INDICATION
SSc-ILD

OFEV is the first antifibrotic therapy FDA-approved to slow the rate of decline in pulmonary function in adults with SSc-ILD3,14

INDICATION
Chronic Fibrosing ILDs with a Progressive Phenotype

OFEV is the only FDA-approved therapy for the treatment of chronic fibrosing-ILDs with a progressive phenotype3,15

OFEV is recommended by ATS/ERS/JRS/ALAT guideline

  • 2015: For the treatment of IPF1*
  • 2022: For the treatment of progressive pulmonary fibrosis (PPF) in patients who have failed standard management for fibrotic ILD, other than IPF2*

OFEV has consistent results across 5 clinical trials

INPULSIS®-1: -115 mL/year for OFEV (nintedanib) (n=309) compared with -240 mL/year for placebo (n=204); P<.001, 95% CI=78, 173.

INPULSIS®-2: -114 mL/year for OFEV (n=329) compared with -207 mL/year for placebo (n=219); P<.001, 95% CI=45, 143.

TOMORROW: -60 mL/year for OFEV (n=84) compared with -191 mL/year for placebo (n=83); P=.01, 95% CI=27, 235.

INBUILD®: -81 mL/year for OFEV (n=331) compared with -188 mL/year for placebo (n=331); P<.001, 95% CI=65, 148.

SENSCIS®: -52 mL/year for OFEV (n=287) compared with -93 mL/year for placebo (n=288); P=.04, 95% CI=3, 79.

CI, confidence interval; FVC, forced vital capacity.

Demonstrated safety and tolerability profile across 5 clinical trials3,6

  • The most common adverse reactions reported (≥5%) were diarrhea, nausea, abdominal pain, vomiting, liver enzyme elevation, decreased appetite, headache, weight decrease, and hypertension3
  • The most common adverse reactions were gastrointestinal in nature and generally of mild to moderate intensity3
  • No new safety concerns identified in SENSCIS® and INBUILD® compared with pivotal IPF trials3,6
  • No overall increased risk of infection compared with placebo16*

*The incidence of infections and infestations was similar in the OFEV (nintedanib) and placebo groups across trials (TOMORROW, INPULSIS®-1, and INPULSIS®-2: 56% vs 55%, respectively; INBUILD®: 53% vs 56%, respectively; and SENSCIS®: 63% vs 64%, respectively).16

Support for your patients

Experience adds up with OFEV1