Thank you, Enrique, and good afternoon, everyone. 2019 was a great year for roxadustat, and I would like to review some of the highlights. The roxadustat NDA was submitted to the FDA for the treatment of anemia in both dialysis-dependent CKD and non-dialysis-dependent CKD patients in December 2019. And FDA has accepted our NDA filing with PDUFA date of December 20, 2020.
Roxadustat was approved in China for the treatment of anemia in NDD CKD patients at the end of in 2018 and for the treatment of NDD CKD anemia in August 2019.
Chris will go into more detail later in the call when she provides an update on FibroGen China. In Japan, roxadustat was approved for the treatment of anemia NDD CKD patients in September 2019 and the supplemental NDA for NDD CKD was submitted this past January.
With positive momentum we look forward to advancing roxadustat in 2020. In the U.S. we continue to support the FDA's review of our NDA and expect approval before the end of the year. There has been no indication at this time the FDA will hold an advisory committee meeting, but we are preparing as if there were one.
To optimize our business success in the U.S., we and our partner AstraZeneca continue commercialization preparation to pave the way for roxadustat to become accessible to patients.
With the robust efficacy and safety profile demonstrated in a large Phase III program of over 8,000 patients, we believe roxadustat can potentially better address a CKD anemia than what is currently available to CKD patients on dialysis and those not on dialysis.
I shall first summarize key positive efficacy and cardiovascular safety results from the over 3,800 patient pool of dialysis-dependent patients where roxadustat was compared to epoetin alfa and patient had a average treatment duration of 1.8 years.
As reported at the ASM Meeting in dialysis patients, roxadustat met the primary efficacy endpoint with larger hemoglobin increase and epoetin alfa in each of the three pivotal studies and in the pool analysis, while mean achieved hemoglobin levels were within the intended range.
Roxadustat-treated patients had lower transfusion risk than EPO patients, while lowering MACE+ risk in the dialysis patient pool. Notably unlike ESA, roxadustat maintain efficacy without increasing dose requirements in the presence of inflammation.
Importantly, less IV iron supplementation was required with roxadustat with EPO.
Within the dialysis patient population, we are particularly excited about the cardiovascular safety results of the incident dialysis of population. These patients entered the study during the first four months of dialysis initiation and had an average treatment duration of 1.5 years.
We enrolled over 1,500 incident dialysis patients in this program, the largest in this population ever conducted.
Here we demonstrated a meaningful reduction in cardiovascular safety risk as roxadustat-treated incident dialysis patients had a 30% lower MACE risk and a 34% lower MACE+ than epoetin alfa treated patients.
We believe the high-risk incident dialysis of population is the right and most appropriate setting for comparison of roxadustat versus the epoetin alfa since most patients are ESA naïve prior to study entry.
Now moving on to our non-dialysis program. I will summarize key positive efficacy and cardiovascular safety results from the over 4,200 pool of non-dialysis dependent patients where roxadustat was compared to placebo.
As a reminder, the vast majority of NDD patients in the U.S. receive no ESA treatment, especially after the ESA label change over the period of 2007 to 2011. And placebo control is the preferred standard for safety comparison.
In NDD patients, roxadustat was superior to placebo in the primary efficacy endpoint of mean change in hemoglobin level from baseline and significantly reduce transfusion risk compared to placebo. Because roxadustat is conducive to iron mobilization, we demonstrate the roxadustat's efficacy in patients with lower iron stores than required for ESA. 40% of the patients in our Phase 3 NDD studies have baseline iron stores below the minimum required for treating – for treatment with ESA and demonstrate the hemoglobin response to roxadustat was similar to that of patients with iron repletion.
With respect to cardiovascular safety, roxadustat was comparable to placebo in risk of MACE and MACE+ while achieved a mean hemoglobin level of 11 grams per deciliter. With this favorable efficacy and safety profile, in addition to the convenience of oral dosing, we believe roxadustat can potentially overcome a number of hurdles of ESAs and expand anemia treatment in MDD patients.
Beyond CKD, we continued development of roxadustat for the treatment of anemia associated with myelodysplastic syndrome for chemotherapy-induced anemia, while evaluating for additional diseases.
Our vision for roxadustat is to become the standard of care for anemia broadly.
Last December, we presented the positive results from the open-label portion of the Phase 3 global study evaluating roxadustat for treatment of anemia in MDS patients at the Annual American Society of Hematology Meeting. In 2019, we also initiated a Phase 2 study in chemotherapy-induced anemia. CIA represents a large patient population, whose anemia is often left untreated to-date.
To make roxadustat available to the rest of the world, our partner AstraZeneca in collaboration with our team is submitting marketing application of roxadustat for CKD anemia in a number of countries. We've already submitted to Canada, Mexico and several Asian countries. It is great to see all this progress in the months following the three prominent scientists including Dr. Will Kaelin, our long time adviser and collaborator were awarded the 2019 Nobel Prize in medicine for discoveries in oxygen sensing, which serve as the important scientific basis for the development of roxadustat.
We appreciate the medical community's strong support for roxadustat and look forward to the opportunity in working with physicians, nurses and patients to improve anemia care globally.
I would now like to turn the call over to Chris Chung, who will discuss the recent developments in China.