Thomas B. Neff who is the chief Executive officer of FibroGen said, “FibroGen continues to make advancements across multiple programs, including anemia, idiopathic pulmonary fibrosis, pancreatic cancer, and Duchenne muscular dystrophy,” and also he added in it, “Through FibroGen’s joint effort with our partners, AstraZeneca and Astellas, the Phase 3 development of roxadustat remains on track. We continue to expect to file the roxadustat regulatory submissions in 2016 for China and 2018 for the United States.”
Further Thomas also added, “As previously announced, our first roxadustat Phase 2 publication appeared on line last week. The article breaks new ground as the first peer-reviewed article ever to feature clinical evidence of hemoglobin correction by a hypoxia inducible factor prolyl hydroxylase inhibitor in anemic patients. Additional manuscripts on roxadustat Phase 2 studies have been submitted for editorial review. We expect this body of scientific literature will reinforce the first-in-class and best-in-class potential of roxadustat for the treatment of anemia in patients with chronic kidney disease.”
“In our fibrosis programs, the FDA cleared our Investigational New Drug application for the study of FG-3019 in Duchenne muscular dystrophy. We plan to begin evaluating the potential anti-fibrotic activity of FG-3019 in non-ambulatory boys with this disease later this year. In addition, we are evaluating expansion of enrollment in our Phase 2 idiopathic pulmonary fibrosis study to include FG-3019 as a combination treatment with approved therapy. Our open label study of FG-3019 in pancreatic cancer continues to advance and we look forward to evaluating potential program expansion once we have sufficient preliminary data from the study.” These all important statements were made by Thomas to tell more about the announcement made for the year 2015 results.