WebSep 30, 2024 · RIDGEFIELD, Conn., Sept. 30, 2024 /PRNewswire/ -- Boehringer Ingelheim announced today that in the Phase III INBUILD® trial Ofev® (nintedanib) slo... 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).
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WebSep 30, 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 tolerability of nintedanib (150 mg, 2 x daily) over 52 weeks in … WebINBUILD compared nintedanib to placebo, randomized 1:1, in 663 patients with PF-ILD. There were 2 parts to the trial, Part A and Part B. Part A consisted of 52 weeks of double-blind treatment with either nintedanib or … cynthia mattox
Nintedanib in Progressive Fibrosing Interstitial Lung …
WebApr 1, 2024 · The INBUILD study reported that, in adult patients with progressive fibrosing interstitial lung disease (PF-ILD), the difference in mortality between nintedanib (NIN) plus best supportive care (BSC) compared with BSC alone was not statistically significant over 52 weeks. However, the assumed and extrapolated difference in mortality is a key driver in … 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 … WebApr 12, 2024 · Based on findings from animal studies and its mechanism of action, OFEV® can cause fetal harm when administered to a pregnant woman. Nintedanib caused embryo-fetal deaths and structural abnormalities in rats and rabbits when administered during organogenesis at less than (rats) and approximately 5 times (rabbits) the maximum … cynthia matson texas a\u0026m san antonio