Throughout the many unprecedented events of 2020, we at FibroGen have continued working towards our goal of delivering first-in-class medicines to patients with chronic and life-threatening conditions.
Most recently, this commitment was on display at the American Society of Nephrology’s Kidney Week 2020 Reimagined where, alongside our partners AstraZeneca and Astellas, we presented new research results on roxadustat, our investigational first-in-class oral treatment for patients with anemia of CKD. The analyses from the 42 presentations (10 oral) presented at Kidney Week add to the understanding of roxadustat’s efficacy and safety profile and medical needs in anemia of chronic kidney disease. Two late-breaking abstracts explored cardiovascular outcomes of patients with anemia of CKD treated with roxadustat, including the associations of Major Adverse Cardiovascular Events (MACE) and MACE+ event rates at various hemoglobin levels.
We also presented data on the burden of anemia for CKD patients and the unmet medical need they share, a tangible reminder that people with anemia of CKD have not had a new treatment option approved in roughly 30 years.
I am proud of the potentially practice-changing science FibroGen continues to contribute and I remain optimistic in our ability to revolutionize the treatment of anemia of CKD. With a Food and Drug Administration action date for roxadustat of December 20, we are excited about the potential to bring roxadustat to patients in the US.
To learn more about our data at Kidney Week 2020 Reimagined, visit our microsite https://www.roxadustatscientificexhibit.com/, and I encourage you to follow FibroGen on Twitter and LinkedIn for company updates and leadership perspectives on Kidney Week and beyond.
Enrique Conterno, CEO
This letter contains forward-looking statements regarding our strategy, future plans and prospects, including statements regarding the development, and the commercialization of roxadustat, the potential safety and efficacy profile of roxadsutat, and upcoming regulatory events. These forward-looking statements include, but are not limited to, statements about our plans, objectives, representations and contentions and are not historical facts. Our actual results may differ materially from those indicated in these forward-looking statements due to risks and uncertainties related to the continued progress and timing of our various programs, including the enrollment and results from ongoing and potential future clinical trials, and other matters that are described in our Annual Report on Form 10-K for the fiscal year ended December 31, 2019 and our Quarterly Report on Form 10-Q for quarter ended June 30, 2020 filed with the Securities and Exchange Commission (SEC), including the risk factors set forth therein. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this letter, and we undertake no obligation to update any forward-looking statement in this letter, except as required by law.