FibroGen (FGEN) provided clarification of certain prior disclosures of U.S. primary cardiovascular safety analyses from roxadustat Phase 3 program for the treatment of anemia of CKD
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FibroGen, Inc. (Nasdaq: FGEN) (the “Company”) today provided clarification of certain prior disclosures of U.S. primary cardiovascular safety analyses from the roxadustat Phase 3 program for the treatment of anemia of chronic kidney disease (“CKD”).
“As members of senior management were preparing for the upcoming FDA Advisory Committee meeting, we became aware that the primary cardiovascular safety analyses included post-hoc changes to the stratification factors,” said Enrique Conterno, Chief Executive Officer, FibroGen. “While all of the analyses set forth below, including the differences in the stratification factors, were included in the NDA, we promptly decided to clarify this issue with the FDA and communicate with the scientific and investment communities.”
Mr. Conterno continued, “It is important to emphasize that this does not impact our conclusion regarding the comparability, with respect to cardiovascular safety, of roxadustat to epoetin-alfa in dialysis-dependent (DD) patients and to placebo in non-dialysis dependent (NDD) patients. We continue to have confidence in roxadustat’s benefit risk profile.”
FibroGen continues to prepare for the FDA Advisory Committee meeting and will work closely with the FDA to bring this important new treatment to patients living with anemia of CKD.
There is no change in the underlying roxadustat data, or to the efficacy analyses from the Phase 3 program. The Company has begun a comprehensive internal review to ensure such issues do not occur in the future.
Pooled Cardiovascular Safety DataAs previously disclosed, the Company agreed with the FDA in the pre-NDA meeting that the primary analysis in non-dialysis would be ITT (intention to treat with long-term follow up) and in dialysis would be OT-7 (on-treatment plus 7 days). MACE, a composite endpoint of all-cause mortality, stroke, and myocardial infarction, was the primary safety endpoint agreed on with the FDA.
The table below describes the cardiovascular safety results using the post-hoc stratification factors reported at the American Society of Nephrology conference in November 2019, as well as the analyses with the pre-specified stratification factors which have not been previously publicly reported.
|Analyses with post-hoc stratification factors||Analyses with pre-specified stratification factors|
|HR (95% Confidence Interval)||HR (95% Confidence Interval)|
|Non Dialysis (OLYMPUS, ANDES, ALPS N=4,270); ITT|
|MACE||1.08 (0.94, 1.24)||1.10 (0.96, 1.27)|
|MACE+||1.04 (0.91, 1.18)||1.07 (0.94, 1.21)|
|ACM||1.06 (0.91, 1.23)||1.08 (0.93, 1.26)|
|Dialysis Dependent (HIMALAYAS, SIERRAS, ROCKIES N=3,880); OT-7|
|MACE||0.96 (0.82, 1.13)||1.02 (0.88, 1.20)|
|MACE+||0.86 (0.74, 0.98)||0.91 (0.80, 1.05)|
|ACM||0.96 (0.79, 1.17)||1.02 (0.84, 1.23)|
|Incident Dialysis (N=1,526); OT-7|
|MACE||0.70 (0.51, 0.96)||0.82 (0.60, 1.11)|
|MACE+||0.66 (0.50, 0.89)||0.78 (0.59, 1.02)|
|ACM||0.76 (0.52, 1.11)||0.82 (0.57, 1.18)|
|ITT: intention to treat with long-term follow up|
|OT-7: on-treatment plus 7 days|
|Major Adverse Cardiovascular Event (MACE): a composite endpoint of all-cause mortality, stroke, and myocardial infarction.|
|(MACE+): in addition to the components in MACE, includes hospitalization due to heart failure or unstable angina.|
|(ACM): all-cause mortality.|
As reflected in the table, the analyses with the pre-specified stratification factors result in higher hazard ratios (point estimates of relative risk) and 95% confidence intervals. For MACE+ in dialysis and for MACE and MACE+ in incident dialysis, the 95% confidence intervals include 1.0. While these hazard ratios remain below 1.0, based on these analyses we cannot conclude that roxadustat reduces the risk of (or is superior to) MACE+ in dialysis, and MACE and MACE+ in incident dialysis compared to epoetin-alfa.
These analyses do not change the Company’s assessment that roxadustat is comparable to placebo in non-dialysis dependent patients and to epoetin-alfa in dialysis dependent patients using MACE to measure cardiovascular safety.
As previously announced, roxadustat has been launched in China and Japan for the treatment of anemia of CKD in both NDD and DD adult patients. These approvals were based on different studies conducted in the relevant geographies. In Europe, the Marketing Authorization Application for roxadustat for the treatment of anemia of CKD in patients both on dialysis and not on dialysis was filed by FibroGen’s partner Astellas and accepted by the European Medicines Agency for review in May 2020.
Conference Call and Webcast Details
FibroGen will host a conference call and webcast today, April 6, 2021, at 5:00 pm Eastern Time (2:00 p.m. Pacific Time) to discuss this matter. Interested parties may access a live audio webcast of the conference call via the FibroGen website at https://fibrogen.gcs-web.com/events-and-presentations/events. It is recommended that listeners access the website 15 minutes prior to the start of the call to download and install any necessary audio software.
Dial-In InformationLive (U.S./Canada): (877) 658-9081Live (International): (602) 563-8732Confirmation number: 5297733
A replay of the webcast and investor presentation will be available shortly after the call for a period of 30 days. To access the replay, please dial (855) 859-2056 (domestic) or (404) 537-3406 (international), and use passcode 5297733.
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