Drugs / Ofev®
Regulatory milestones approvals, filings & regulatory actions · 5 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed pulmonary fibrosis 1 milestone | |||||
| Filed | US (FDA) | OFEV | pulmonary fibrosis | 2023-07-25 | “the U.S. Food and Drug Administration (FDA) accepted its supplemental New Drug Application (sNDA) for OFEV (nintedanib)” prnewswire.com ↗ |
| Filed pulmonary systemic sclerosis 4 milestones | |||||
| Filed | EU (EMA) | OFEV | pulmonary systemic sclerosis | 2019-08-15 | “submeteu um pedido de aprovação ao FDA e à Agência Europeia de Medicamentos (EMA) para uma nova indicação do medicamento OFEV® (nintedanibe)” prnewswire.com ↗ |
| Filed | US (FDA) | OFEV | pulmonary systemic sclerosis | 2019-08-15 | “submeteu um pedido de aprovação ao FDA e à Agência Europeia de Medicamentos (EMA) para uma nova indicação do medicamento OFEV® (nintedanibe)” prnewswire.com ↗ |
| Filed | EU (EMA) | Ofev | pulmonary systemic sclerosis | 2019-03-18 | “Boehringer Ingelheim has filed for regulatory approval of nintedanib in patients with systemic sclerosis associated interstitial lung disease (SSc-ILD) with the FDA and EMA.” prnewswire.com ↗ |
| Filed | US (FDA) | Ofev | pulmonary systemic sclerosis | 2019-03-18 | “Boehringer Ingelheim has filed for regulatory approval of nintedanib in patients with systemic sclerosis associated interstitial lung disease (SSc-ILD) with the FDA and EMA.” prnewswire.com ↗ “Ofev® (nintedanib), which is currently under FDA review for the treatment of people with chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype.” prnewswire.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT05262751 | Mar → Nov 2022 | — | Boehringer Ingelheim | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 32
| Date | Issuer | Release |
|---|---|---|
| 2023-07-25 | Boehringer Ingelheim | Regulatory U.S. FDA accepts supplemental New Drug Application for OFEV® (nintedanib) for children and adolescents aged 6-17 years old with fibrosing interstitial lung disease prnewswire.com ↗ |
| 2022-09-05 | Boehringer Ingelheim | Results New data from Boehringer Ingelheim support the potential use of nintedanib in children and adolescents with fibrosing interstitial lung disease prnewswire.com ↗
The trial showed encouraging data for both primary endpoints and results were published in the European Respiratory Journal (ERJ) and presented at the European Respiratory Society (ERS) International Congress in Barcelona, Spain . |
| 2021-05-14 | Boehringer Ingelheim | Results Study analysis available during ATS 2021 supports long-term treatment with Ofev® in patients with systemic sclerosis-associated interstitial lung disease prnewswire.com ↗
In an analysis of SENSCIS-ON, the safety profile of Ofev in participants who continued therapy for an additional 52 weeks was consistent with that observed during the SENSCIS trial. |
| 2020-11-05 | Boehringer Ingelheim | Results New analysis supports long-term treatment with Ofev® in SSc-ILD patients prnewswire.com ↗
Boehringer Ingelheim today announced results from an interim analysis of the SENSCIS®-ON trial evaluating Ofev® (nintedanib) in patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD). |
| 2020-08-05 | Boehringer Ingelheim | Results New Analyses of Ofev® data in patients with chronic fibrosing ILDs available during American Thoracic Society Congress prnewswire.com ↗
Ofev reduced the percent of patients experiencing an absolute decline in FVC >5% predicted, 43.4% compared to 55% for placebo, at 52 weeks. |
| 2020-07-09 | Boehringer Ingelheim | Regulatory ANVISA aprova novo tratamento para doença rara pulmonar prnewswire.com ↗
O medicamento nintedanibe, da farmacêutica Boehringer Ingelheim, recebeu aprovação da Agência Nacional de Vigilância Sanitária (ANVISA)[2] para doenças pulmonares intersticiais (DPIs) fibrosantes com fenótipo progressivo, uma condição crônica, na qual a fibrose pulmonar continua a piorar. |
| 2020-03-09 | Boehringer Ingelheim | Regulatory FDA approves Ofev® as first treatment for chronic fibrosing ILDs with a progressive phenotype prnewswire.com ↗
Boehringer Ingelheim today announced that the U.S. Food and Drug Administration (FDA) approved Ofev® (nintedanib) as the first treatment for people with chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype. |
| 2020-02-17 | Boehringer Ingelheim | Regulatory Boehringer Ingelheim lança tratamento específico para controle da perda da função pulmonar para pacientes com esclerose sistêmica (ES) prnewswire.com ↗
Entretanto, com a aprovação da nova indicação terapêutica do nintedanibe pela Anvisa, o medicamento passa a ser o único no país para o tratamento (ou manejo) da doença pulmonar intersticial associada à esclerose sistêmica (DPI-ES) 2 . |
| 2019-12-18 | Boehringer Ingelheim | Regulatory Ofev® (nintedanibe) da Boehringer Ingelheim é aprovado pela Anvisa para o tratamento de doença pulmonar intersticial associada à esclerose sistêmica (DPI-ES)¹ prnewswire.com ↗ |
| 2019-11-07 | Boehringer Ingelheim | Results New analysis of patients with autoimmune-related ILDs in the INBUILD study shown as poster presentation at the 2019 ACR/ARP Annual Meeting prnewswire.com ↗
Boehringer Ingelheim presented results from a new subgroup analyses that support the primary endpoint results from the Phase III INBUILD ® trial that showed Ofev ® (nintedanib) reduced the rate of lung function decline in patients with autoimmune-related interstitial lung diseases (ILDs). |
| 2019-10-10 | Boehringer Ingelheim | Regulatory FDA Grants Ofev® Breakthrough Therapy Designation for Chronic Fibrosing ILDs with a Progressive Phenotype prnewswire.com ↗
Boehringer Ingelheim announced today that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation to Ofev® (nintedanib), which is currently under FDA review for the treatment of people with chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype. |
| 2019-09-30 | Boehringer Ingelheim | Results INBUILD® meets primary endpoint: study evaluated Ofev® in patients across a range of progressive fibrosing interstitial lung diseases prnewswire.com ↗
Just published in the New England Journal of Medicine and presented at the European Respiratory Society (ERS) Congress in Madrid, Spain , the study met its primary endpoint in patients with a broad range of fibrosing ILDs other than idiopathic pulmonary fibrosis (IPF). |
| 2019-09-09 | Boehringer Ingelheim | Regulatory FDA approves Ofev® as the first and only therapy to slow the rate of decline in pulmonary function in patients with systemic sclerosis-associated ILD prnewswire.com ↗
Boehringer Ingelheim today announced that the U.S. Food and Drug Administration (FDA) approved Ofev ® (nintedanib) as the first and only medicine to slow the rate of decline in pulmonary function in patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD). |
| 2019-07-25 | Boehringer Ingelheim | Regulatory FDA Advisory Committee Recommends Approval of Ofev® for the Treatment of Systemic Sclerosis Associated ILD prnewswire.com ↗
Boehringer Ingelheim today announced that the FDA's Arthritis Advisory Committee recommended (10-7 vote) to approve Ofev® (nintedanib) for the treatment of systemic sclerosis associated interstitial lung disease, or SSc-ILD. |
| 2019-05-20 | Boehringer Ingelheim | Results Phase III study showed Ofev® slows the loss of pulmonary function in people living with systemic sclerosis associated ILD prnewswire.com ↗
Results showed that Ofev® (nintedanib) slows the loss of pulmonary function by 44% in patients with SSc-ILD relative to placebo, as measured by FVC over 52 weeks. |
| 2019-03-18 | Boehringer Ingelheim | Regulatory Boehringer Ingelheim announces FDA and EMA regulatory submission for nintedanib in systemic sclerosis associated ILD prnewswire.com ↗
Boehringer Ingelheim has filed for regulatory approval of nintedanib in patients with systemic sclerosis associated interstitial lung disease (SSc-ILD) with the FDA and EMA. |
| 2018-09-17 | Boehringer Ingelheim | Results New study results provide evidence that Ofev® (nintedanib) slows progression of IPF beyond four years with consistent safety prnewswire.com ↗
These data suggest that the effect of Ofev on slowing disease progression of IPF persists beyond four years. |
| 2018-05-21 | Boehringer Ingelheim | Results Efficacy and safety of Ofev® (nintedanib) reinforced in new presentations at ATS 2018 prnewswire.com ↗
Based on these differences, the analysis suggests that Ofev may be associated with a 26.8% relative reduction in the risk of death compared with placebo over one year. |
| 2018-03-19 | Boehringer Ingelheim | Regulatory FDA grants Fast Track designation to nintedanib for the treatment of systemic sclerosis with associated interstitial lung disease prnewswire.com ↗
Boehringer Ingelheim announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to nintedanib for the treatment of systemic sclerosis with associated interstitial lung disease (SSc-ILD). |
| 2017-10-23 | Boehringer Ingelheim | Results Ofev® demonstrates consistent long-term efficacy in IPF regardless of baseline lung function prnewswire.com ↗
Ofev demonstrated a consistent slowing in the annual rate of decline in lung function, as measured by forced vital capacity (FVC), over 96 weeks regardless of baseline FVC. |
| 2017-09-11 | Boehringer Ingelheim | Results Results from the INJOURNEY™ trial investigating Ofev® with add-on pirfenidone provide new insights into this combination treatment for IPF prnewswire.com ↗
The data show that the safety and tolerability profile of nintedanib with add-on pirfenidone is consistent with the known profiles of the individual drugs in patients with IPF. |
| 2017-05-24 | Boehringer Ingelheim | Results IPF patients treated with Ofev® (nintedanib) versus placebo were twice as likely to have improved or stable lung function prnewswire.com ↗
Overall, the incidence of MACE was similar between the treatment groups both in patients with a high CV risk (3.5%, Ofev vs. 3.3%, placebo) and low CV risk (4.5%, Ofev vs. 5.3%, placebo) at baseline. |
| 2016-10-24 | Boehringer Ingelheim | Results Efficacy of Ofev® (nintedanib) Reinforced in Range of Patients with IPF in New Analyses Presented at CHEST prnewswire.com ↗
The analysis showed a similar reduction in disease progression with Ofev versus placebo regardless of GAP stage (no significant difference between GAP stage I versus GAP stage II/III). |
| 2016-09-07 | Boehringer Ingelheim | Results New Long-Term Data Demonstrates Continued Safety and Beneficial Effect of Ofev® (Nintedanib) for Patients with IPF prnewswire.com ↗
The results demonstrated that Ofev has a long-term effect on slowing disease progression and a manageable side effect profile in patients with IPF, and were consistent with results previously observed in the INPULSIS® trials. |
| 2016-06-27 | Boehringer Ingelheim | Results New analysis of INPULSIS™ trials demonstrates efficacy of OFEV® (nintedanib) across a range of IPF patients using broader diagnostic criteria prnewswire.com ↗
In patients with confirmed UIP pattern, including honeycombing and/or biopsy, the adjusted annual rate of decline in FVC was −108.7 mL/year in the nintedanib group and -225.7 mL/year in the placebo group (difference versus placebo of 117.0 mL/year). |
| 2016-05-16 | Boehringer Ingelheim | Results New Presentations at ATS 2016 Reinforce OFEV® (nintedanib) Efficacy, Safety and Tolerability Across Range of Patients with IPF prnewswire.com ↗
OFEV significantly reduced the risk of a first investigator-reported acute exacerbation (reported as a serious adverse event) by 43% versus placebo based on pooled data from the INPULSIS trials. |
| 2016-02-25 | Boehringer Ingelheim | Results New analysis confirms OFEV® (nintedanib) slows disease progression in IPF and reduces risk of acute exacerbations prnewswire.com ↗
Pooled analysis from the TOMORROW and INPULSIS® trials, recently published in Respiratory Medicine , confirmed that OFEV reduces the risk of acute exacerbations by approximately 50% in people with idiopathic pulmonary fibrosis (IPF), a rare and serious lung disease. |
| 2015-11-13 | Boehringer Ingelheim | Results New Analyses Further Add to the Efficacy and Safety Profile of OFEV® (nintedanib) in Idiopathic Pulmonary Fibrosis (IPF) prnewswire.com ↗
In a post-marketing surveillance study in the United States , treatment with OFEV in the real-world clinical setting showed a safety profile consistent with that observed in clinical trials supporting its approval by the FDA. |
| 2015-10-26 | Boehringer Ingelheim | Results New Analyses Showed Consistent Efficacy of OFEV® (nintedanib) Across Various Patient Populations with Idiopathic Pulmonary Fibrosis (IPF) prnewswire.com ↗
This new analysis showed that OFEV is comparably effective in people with IPF regardless of where they were enrolled in the trial. |
| 2015-09-29 | Boehringer Ingelheim | Results New Data Shows OFEV® (nintedanib) Efficacy is Sustained Long-term with No New Safety Signals in Patients with IPF prnewswire.com ↗
An interim analysis of the INPULSIS™-ON open-label extension trial of OFEV® (nintedanib) shows efficacy and safety that is consistent to that in the two identically-designed Phase III INPULSIS™ trials in patients with idiopathic pulmonary fibrosis (IPF). |
| 2015-05-18 | Boehringer Ingelheim | Results Boehringer Ingelheim Presents New Data and Analyses Reinforcing the Safety and Efficacy of OFEV® (nintedanib) Capsules prnewswire.com ↗
Boehringer Ingelheim announced new data and analyses that provide further evidence to support the efficacy, safety and tolerability of OFEV® (nintedanib) capsules in patients with idiopathic pulmonary fibrosis (IPF). |
| 2014-10-15 | Boehringer Ingelheim | Regulatory FDA Approves Boehringer Ingelheim's OFEV® (nintedanib) as First Kinase Inhibitor to Treat Idiopathic Pulmonary Fibrosis prnewswire.com ↗
Boehringer Ingelheim Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) approved OFEV® (nintedanib) capsules for oral use for the treatment of idiopathic pulmonary fibrosis (IPF). |
All press releases naming this drug 36 releases
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Ofev | “Each participant received: Nintedanib formulation 1: Monolithic Nintedanib Modified Release Tablet (MR1) as two Prototypes (MR1-1 and MR1-2), compared to the reference (R)...” NCT05262751 ↗ |
| Route | Oral | “following oral administration” NCT05262751 ↗ |