RIDGEFIELD, Conn. and INGELHEIM, Germany, July 25, 2023 /PRNewswire/ -- Boehringer Ingelheim announced today that the U.S. Food and Drug Administration (FDA) accepted its supplemental New Drug Application (sNDA) for OFEV (nintedanib), investigating a potential treatment for children and adolescents between 6 to 17 years old with fibrosing interstitial lung disease (ILD).
Lotus' Generic Nintedanib Esylate Receives Approval in the U.S.
Lotus' Generic Nintedanib Receives Approval in the U.S.
INGELHEIM, Germany & RIDGEFIELD, Conn.--(BUSINESS WIRE)--Today, Boehringer Ingelheim announced Phase III data from the InPedILD trial, which assessed the pharmacokinetics (dosing) and safety profile of nintedanib in children and adolescents between 6 and 17 years old with clinically significant fibrosing interstitial lung disease (ILD). 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 International Congress (ERS) in Barcelona, Spain.1
The National Institute for Health and Care Excellence (NICE) has recommended Boehringer Ingelheim’s Ofev (nintedanib) for the treatment of adult patients with chronic fibrosing interstitial lung diseases with a progressive phenotype (PF-ILD).
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Blade Therapeutics, Inc. (Blade or the Company), a biopharmaceutical company focused on developing cutting-edge treatments for fibrotic and neurodegenerative diseases, today announced positive preliminary data from a new preclinical study of cudetaxestat, an investigational non-competitive autotaxin inhibitor in clinical development for IPF. This preclinical study was designed to understand whether the plasma concentration of nintedanib is altered when co-administered at steady state with either cudetaxestat or GLPG-1690 (ziritaxestat).
The Scottish Medicines Consortium (SMC) has approved nintedanib for NHSScotland for the treatment of adult patients with chronic fibrosing interstitial lung diseases with a progressive phenotype (PF-ILD).
RIDGEFIELD, Conn., May 14, 2021 /PRNewswire/ -- Boehringer Ingelheim today announced results from an analysis of the SENSCIS®-ON trial. SENSCIS-ON is an open-label extension trial of the Phase III SENSCIS® study to assess the long-term tolerability and safety of Ofev® (nintedanib) in patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD). The study also evaluated the change from baseline in forced vital capacity (FVC), a measure of lung function, over 52 weeks.
Burlington, ON, March 4, 2021 /CNW/ - Boehringer Ingelheim (Canada) Ltd. is pleased to announce positive recommendations from the Canadian Agency for Drugs and Technologies in Health (CADTH) and the Institut national d'excellence en santé et services sociaux (INESSS) for OFEV® (nintedanib) for the treatment of chronic fibrosing interstitial lung diseases with a progressive phenotype (also known as PF-ILD) when certain conditions are met.4,5
The Icahn School of Medicine at Mount Sinai, Department of Medicine's Clinical Trials Office and Boehringer Ingelheim have enrolled the first patient to evaluate nintedanib in adult patients with acute lung injury following Covid-19 infection.