MedPath

US FDA Accepts NDA Filing for BI's Nintedanib

The US FDA has accepted Boehringer Ingelheim's New Drug Application for nintedanib, granting it Priority Review for treating idiopathic pulmonary fibrosis, a rare and fatal lung disease with no current FDA-approved treatments.

The US Food and Drug Administration (FDA) has accepted Boehringer Ingelheim's (BI) New Drug Application (NDA) for its investigational compound nintedanib, granting it Priority Review designation. This application is under review for the treatment of idiopathic pulmonary fibrosis (IPF), a rare, progressive, and fatal lung disease that currently has no FDA-approved treatments.
The NDA package includes results from two global Phase III studies (INPULSIS-1 and INPULSIS-2) that evaluated the efficacy and safety of nintedanib in treating IPF. Nintedanib, an investigational small molecule tyrosine kinase inhibitor (TKI), targets growth factors potentially involved in pulmonary fibrosis, including the vascular endothelial growth factor receptor (VEGFR), fibroblast growth factor receptor (FGFR), and platelet-derived growth factor receptor (PDGFR).
In June 2011, nintedanib was granted orphan drug designation in the US, highlighting its potential to address a significant unmet medical need in the treatment of IPF.
Subscribe Icon

Stay Updated with Our Daily Newsletter

Get the latest pharmaceutical insights, research highlights, and industry updates delivered to your inbox every day.

Related Topics

Infigratinib Receives FDA Breakthrough Therapy Designation for Achondroplasia

The FDA granted Breakthrough Therapy Designation to BridgeBio's infigratinib for treating children with achondroplasia, a genetic bone growth disorder.
Phase 2 PROPEL 2 trial data showed infigratinib led to a statistically significant increase in annualized height velocity (AHV) in children.

Nerandomilast Shows Promise in Phase 3 Trial for Idiopathic Pulmonary Fibrosis

Boehringer Ingelheim's nerandomilast met its primary endpoint in the Phase 3 FIBRONEER-IPF trial, demonstrating improved lung function in IPF patients.
The trial is the first in a decade to meet its primary endpoint, offering hope for a new treatment option for this progressive disease.

Nerandomilast Meets Primary Endpoint in Phase III FIBRONEER-IPF Trial

Boehringer Ingelheim's nerandomilast met the primary endpoint in the Phase III FIBRONEER-IPF trial, showing a significant absolute change from baseline in Forced Vital Capacity (FVC) at week 52 compared to placebo.
The FIBRONEER-IPF trial, the largest IPF trial to date, recruited patients from over 330 sites across more than 30 countries, demonstrating broad global participation.

Boehringer Ingelheim Seeks Approval for Nerandomilast After Positive Phase III IPF Trial

Boehringer Ingelheim is seeking regulatory approval for nerandomilast after its Phase III FIBRONEER-IPF trial met the primary endpoint of improving forced vital capacity in patients with idiopathic pulmonary fibrosis (IPF).
The FIBRONEER-IPF trial, involving 1,177 patients, demonstrated that nerandomilast significantly improved lung function compared to placebo over 52 weeks; full data will be presented in H1 2025.

Nerandomilast Meets Primary Endpoint in Phase III FIBRONEER-IPF Trial for Idiopathic Pulmonary Fibrosis

Boehringer Ingelheim's FIBRONEER-IPF trial met its primary endpoint, demonstrating a statistically significant change in Forced Vital Capacity (FVC) at week 52 compared to placebo.
Nerandomilast, an oral phosphodiesterase 4B (PDE4B) inhibitor, is under investigation for treating Idiopathic Pulmonary Fibrosis (IPF) and has received FDA Breakthrough Therapy Designation.

Nerandomilast Meets Primary Endpoint in Phase III FIBRONEER-IPF Trial

Boehringer Ingelheim's nerandomilast met the primary endpoint in the Phase III FIBRONEER-IPF trial, showing a significant change in Forced Vital Capacity (FVC) at week 52 compared to placebo.
The FIBRONEER-IPF trial, the largest IPF trial to date, recruited patients from over 330 sites across more than 30 countries, demonstrating broad global participation.

Nerandomilast Meets Primary Endpoint in Phase III FIBRONEER-IPF Trial for Idiopathic Pulmonary Fibrosis

Nerandomilast met the primary endpoint in the FIBRONEER-IPF trial, demonstrating a statistically significant absolute change from baseline in Forced Vital Capacity (FVC) at week 52 compared to placebo.
The FIBRONEER-IPF trial, involving over 1177 patients across more than 30 countries, stands as the largest IPF trial conducted to date.

Mirdametinib's NDA for NF1-PN Granted Priority Review by FDA

The FDA has granted priority review to SpringWorks Therapeutics' NDA for mirdametinib in treating Neurofibromatosis Type 1-associated plexiform neurofibromas (NF1-PN).
The PDUFA target action date is set for February 28, 2025, with the FDA indicating no current plans for an advisory committee meeting.

FDA Grants Priority Review to IntraBio's IB1001 for Niemann-Pick Disease Type C

The FDA has accepted IntraBio's New Drug Application for IB1001, granting Priority Review for Niemann-Pick Disease Type C treatment.
IB1001's NDA is supported by positive Phase 3 trial results, demonstrating improvements in neurological symptoms and quality of life.

Annovis Bio's Buntanetap Phase 3 Alzheimer's Trial Streamlined Following FDA Agreement

The FDA has accepted an updated protocol for Annovis Bio's pivotal Phase 3 Alzheimer's disease study, slated to begin in January 2025.
The revised protocol integrates two separate trials into a single 6/18-month trial to assess both symptomatic and disease-modifying effects of buntanetap.

Reference News

[1]
US FDA Accepts NDA filing for BI's Nintedanib
pharmaphorum.com · Jul 6, 2014

Boehringer Ingelheim's NDA for nintedanib, targeting idiopathic pulmonary fibrosis (IPF), accepted by FDA with Priority ...

© Copyright 2025. All Rights Reserved by MedPath
HomeTerms & ConditionsPrivacy Policy