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Nintedanib is used for the treatment of idiopathic pulmonary fibrosis. [9] It has been shown to slow down decrease in forced vital capacity, [10] [11] and it also improves people's quality of life. [12] Nintedanib does not improve survival in people with IPF. [13]
[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 ...
Zanidatamab, sold under the brand name Ziihera, is a humanized monoclonal antibody used for the treatment of HER2-positive biliary tract cancer. [1] [2] It is an IgG-like bispecific HER2-directed antibody directed against two non-overlapping domains of HER2.
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 ...
Admilparant is an investigational new drug being developed by Bristol-Myers Squibb for the treatment of idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF). It is a first-in-class lysophosphatidic acid receptor 1 (LPA1) antagonist. [1] [2] As of 2024, admilparant is in Phase III clinical trials for both IPF and PPF. [2] [3]
An Abbreviated New Drug Application (ANDA) is an application for a U.S. generic drug approval for an existing licensed medication or approved drug.. The ANDA is submitted to FDA's Center for Drug Evaluation and Research, Office of Generic Drugs, which provides for the review and ultimate approval of a generic drug product.
Zenocutuzumab, sold under the brand name Bizengri, is a humanized monoclonal antibody used for the treatment of non-small cell lung cancer or pancreatic cancer. [1] It is a low-fucose humanized full-length immunoglobulin G1 bispecific HER2- and HER3-directed antibody.