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Nintedanib was approved for idiopathic pulmonary fibrosis on 15 October 2014, by the United States Food and Drug Administration (FDA), [30] and received a positive opinion from the European Medicines Agency in November 2014, being approved in the European Union in January 2015.
Patients with idiopathic pulmonary fibrosis were randomly assigned to treatment with oral pirfenidone or placebo for a minimum of 72 weeks. [47] In study 004, pirfenidone reduced decline in forced vital capacity. Mean change in FVC at week 72 was –8.0% in the pirfenidone 2403 mg/day group and –12.4% in the placebo group, a difference of 4.4%.
1.3 Clinical studies The clinical efficacy and safety of nintedanib in IPF has been established in 1,231 patients with IPF in one Phase II clinical trial (TOMORROW) and two replicate Phase III clinical trials, INPULSIS®-1 and -2.[18][21] These were double blind, randomised and placebo-controlled trialscomparing treatment with nintedanib 150 mg ...
[3] [12] A recent study from the US estimated the incidence of IPF to be between 6.8 and 16.3 per 100,000 persons. In the 27 European Union countries, a range of sources estimate an incidence of 4.6–7.4 people per 100,000 of the population, [ 73 ] [ 74 ] suggesting that approximately 30,000–35,000 new patients will be diagnosed with IPF ...
[1] [3] [6] But in most cases the cause is unknown (idiopathic pulmonary fibrosis). [1] [3] Diagnosis may be based on symptoms, medical imaging, lung biopsy, and lung function tests. [1] No cure exists and treatment options are limited. [1] Treatment is directed toward improving symptoms and may include oxygen therapy and pulmonary rehabilitation.
Since the medical term for conditions of unknown cause is "idiopathic", the clinical term for UIP of unknown cause is idiopathic pulmonary fibrosis (IPF). [2] Examples of known causes of UIP include connective tissue diseases (primarily rheumatoid arthritis ), drug toxicity, chronic hypersensitivity pneumonitis , asbestosis and Hermansky ...
Ziritaxestat is a small-molecule, selective autotaxin inhibitor that was investigated as a potential treatment for idiopathic pulmonary fibrosis (IPF). [1] Initially showing promise in early-phase studies, ziritaxestat underwent evaluation in two large-scale phase 3 clinical trials, ISABELA 1 and ISABELA 2.
The strategy of development of setanaxib was initially focused on the treatment of fibrosis and particularly idiopathic pulmonary fibrosis (IPF). Setanaxib obtained orphan drug designation from regulatory agencies in the US and EU in early 2010. [12] It was later granted FDA Fast Track Designation in PBC in August 2021. [13]
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