WebOct 10, 2024 · The most common side effects of Ofev are diarrhea, nausea, stomach pain, vomiting, liver problems, decreased appetite, headache, weight loss, and high blood pressure. These are not all the... WebRidgefield, Conn., October 10, 2024 – 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.
Ofev Approved for Chronic Fibrosing Interstitial Lung Disease with ...
WebOct 14, 2024 · The breakthrough designation for the treatment of progressive ILDs was granted based on findings from the Phase 3 INBUILD trial (NCT02999178).The study, sponsored by Boehringer Ingelheim, enrolled 663 adult patients with progressive ILDs other than IPF who were randomly assigned to receive either Ofev (administered at a dose of … WebAug 5, 2024 · The INBUILD trial was a randomized, double-blind, placebo-controlled, parallel group trial conducted at 153 sites in 15 countries that evaluated the efficacy and safety of … list of foods with grain
Executive Summary - Clinical Review Report: …
WebOct 9, 2024 · BURLINGTON, ON, Oct. 9, 2024 /CNW/ - Boehringer Ingelheim announced today that in the Phase III INBUILD ® trial nintedanib slowed lung function decline by 57% across the overall study population, as assessed by the annual rate of decline in forced vital capacity (FVC) i over 52 weeks in patients with chronic fibrosing interstitial lung disease … WebOct 26, 2024 · Patients with a recent history of myocardial infarction or stroke were excluded from the clinical trials. In the clinical trials, arterial thromboembolic events were infrequently reported (Ofev 2.5% versus placebo 0.7% for INPULSIS; Ofev 0.9% versus placebo 0.9% for INBUILD; Ofev 0.7% versus placebo 0.7% for SENSCIS). WebNov 7, 2024 · In September 2024, Ofev was approved in the U.S. as the first and only therapy to slow the rate of decline in pulmonary function in patients with systemic sclerosis … imaginext toys space shuttle