The New Drug Application (NDA) for Roxadustat has been accepted for the treatment of anemia in Chronic Kidney Disease (CKD). Market Insight: Roxadustat, the approved drug, is the pioneer in the class of hypoxia-inducible factor prolyl hydroxylase inhibitors. Its potential market could reach a billion dollars in the years to come. Patient Pool: Globally, an estimated 10-12% of the adult population suffers from CKD, with over 14% of the adult population in the United States affected by CKD, as reported by the United States Renal Data System (USRDS). Key Players: Leading pharmaceutical companies, including FibroGen, AstraZeneca, and Astellas Pharma, are pivotal in this market, with a focus on emerging markets. Anemia is a common condition associated with Chronic Kidney Disease (CKD), encompassing myelodysplastic syndromes (MDS) and chemotherapy-induced anemia (CIA). Anemia often develops in the early stages of CKD, typically when kidney function is reduced to 20-50% of normal capacity. Its severity tends to increase as CKD progresses. The primary cause is the inadequate production of erythropoietin (EPO), a hormone typically generated by the kidneys. This results in reduced red blood cell production in the bone marrow, leading to anemia. Complications may include irregular or unusually rapid heartbeats. Introduction to Roxadustat: Roxadustat is a small molecule hypoxia-inducible factor (HIF) prolyl hydroxylase inhibitor. Route of Administration: Roxadustat is administered orally. Treatment Scope: Roxadustat is used for the treatment of anemia in patients with dialysis-dependent chronic kidney disease (CKD), non-dialysis-dependent CKD, and those with myelodysplastic syndromes.

1. NDA OF ROXADUSTAT WAS
ACCEPTED IN THE TREATMENT OF
ANEMIA IN CKD
By Pranay Kumar
:- pranayraju66@gmail.com

2. ❑ Executive Summary
❑ Overview
❑ Roxadustat Journey
❑ Industry Insight
❑ Clinical Trails Insight: Phase-III
❑ Insights
2
TableOfContent

3. 3
Executive Summary
Roxadustat - Treatment of
Anemia in CKD
Key Players
Market Insight
Patient Pool Focus
• FibroGen
• AstraZeneca
• Astellas Pharma
• The approved roxadustat drug is first
in the hypoxia-inducible factor prolyl
hydroxylase inhibitor class.
• Roxadustat can hold a billion-dollar
market in the coming years.
• The prevalence of CKD in the
adult population is estimated at
10-12% globally.
• Over 14% of the U.S. adult
population is affected by CKD,
according to the United States
Renal Data System (USRDS).
• Emerging market.
• Anemia is associated with
myelodysplastic syndromes (MDS).
• Chemotherapy-induced anemia (CIA).

4. Introduction: Anemia in CKD
4
Overview
Introduction: Roxadustat
❑ Roxadustat is a small molecule hypoxia-inducible factor (HIF) prolyl
hydroxylase inhibitor.
❑ Route of administration:
❑ Oral
❑ Treatment:
❑ Anemia in patients with dialysis-dependent chronic kidney
disease (CKD), non-dialysis-dependent CKD and in patients with
myelodysplastic syndromes.
Source: https://www.niddk.nih.gov/health-information/kidney-disease/anemia#:~:text=What%20causes%20anemia%20in%20chronic,of%20the%20oxygen%20it%20needs,
https://www.kidney.org/atoz/content/what_anemia_ckd, https://www.fiercepharma.com/special-report/4-Roxadustat, https://pubmed.ncbi.nlm.nih.gov/30805897/
❖ Anemia in CKD (chronic kidney disease) patient is the most
common disease.
❖ Anemia might initiate to develop in the early stages of CKD, when
someone has 20 - 50% of normal kidney function.
❖ Anemia tends to worsen as CKD progresses.
❖ Kidney do not make enough EPO (erythropoietin), hormone
produce by kidney.
❖ Results:
❖ The bone marrow makes fewer red blood cells which cause
anemia.
❖ Complications:
❖ Irregular heartbeat or an unusually fast heartbeat.

5. 5
Roxadustat Journey
Source: Refer to secondary research excel.
2018 2020
• Obtained approval process – China
Insight
• Marketing authorization application accepted – Europe
• NDA review process completed – U.S.
Insight
2019
• Marketing authorization – China
• Approved – Japan
• Application Submit – U.S
• Application Submit – India
Insight

6. 6
Industry Insight
Source: Refer to secondary research excel.
Year Type Country Details Outcome
December, 2018
Obtained approval
process
China
AstraZeneca and FibroGen Medical Technology
Development have obtained approval from the China
National Medical Products Administration (NMPA) to
market roxadustat medicine for the treatment of anemia
caused due to chronic kidney disease (CKD).
The drug is expected to launch in China in
the second half - 2019.
August, 2019
Marketing
authorization
China
AstraZeneca announced that its partner FibroGen (China)
Medical Technology Development Co., Ltd. (FibroGen
China) has received marketing authorization for roxadustat
in China for the treatment of anemia caused by chronic
kidney disease (CKD) in non-dialysis-dependent (NDD)
patients.
Approved in China for the treatment of
patients with anemia from CKD on dialysis
and not on dialysis.
December, 2019 Application Submit U.S
FibroGen announced the submission of a New Drug
Application (NDA) to the U.S. Food and Drug Administration
(FDA) for roxadustat for the treatment of anemia of chronic
kidney disease (CKD), in both non-dialysis-dependent
(NDD) and dialysis-dependent (DD) CKD patients.
The submission of this NDA is a major step
toward our goal of bringing this novel oral
medicine to U.S. patients suffering from
anemia in CKD.
February, 2020
NDA review process
completed
U.S
FibroGen announced that the U.S. Food and Drug
Administration (FDA) has completed its filing review of its
New Drug Application (NDA) for roxadustat for the
treatment of anemia of chronic kidney disease (CKD), in
both non-dialysis-dependent (NDD) and dialysis-dependent
(DD) patients.
The application will be considered filed on
February 18, 2020. The FDA has set a
Prescription Drug User Fee Act (PDUFA)
date of December 20, 2020.
1/2

7. 7
Industry Insight
Source: Refer to secondary research excel.
Year Type Country Details Outcome
May, 2020
Marketing
authorization
application accepted
Europe
Astellas Pharma and FibroGen announced the marketing
authorization application (MAA) for roxadustat for the
treatment of anemia in adult patients with chronic kidney
disease (CKD) has been accepted by the European
Medicines Agency (EMA) for regulatory review.
Approve oral therapeutic option in the EU
for the management of anemia in adults
with chronic kidney disease.
November, 2019 Approval process India
Astrazeneca seek for regulatory clearance for the
commercialization of the company’s anemia drug
roxadustat in India.
Approve drug for anemia in chronic kidney
disease (CKD).
September, 2019 Approved Japan
Astellas Pharma and FibroGen announced that Japan’s
Ministry of Health, Labour and Welfare (MHLW) approved
Evrenzo® (generic name: roxadustat) for the treatment of
anemia associated with chronic kidney disease (CKD) in
dialysis patients.
New therapy to CKD anemia patients on
dialysis in Japan.
2/2

8. 8
Clinical TrailsInsight: Phase-III
Source: https://clinicaltrials.gov/
Identifier
Estimated
Patients
Study Design Intervention
Primary
Endpoint
Country Follow-up Status
NCT02174731 2100 dialysis patients
Multicenter,
randomized,
open-label, active
controlled
Roxadustat
Epoetin alfa
Mean change in Hb
from baseline to week
52
Major adverse
cardiovascular ((CV)
events (MACE)
North, Central and
South America,
Europe, Australia,
India, Philippine
Event-driven,
anticipate 1-2 years
Recruiting
NCT02278341 838 dialysis patients
Randomized, Open-
Label, Active-
Controlled
Roxadustat
epoetin alfa
darbepoetin alfa
EU: Hb change from
baseline to week 36
without rescue
therapy
US: Hb change from
baseline to 52
regardless of
rescue therapy
Europe
A minimum of
52 weeks up to
a maximum of
104 weeks
Active, not Recruiting
NCT02964936
100 ES Anaives
NDCKD patients
Multicenter,
randomized, 2-arm,
Open-label
Roxadustat
Hb change from
baseline to week 24
Japan
Hb change from
baseline to week 24
Recruiting

9. 9
Insights
Potential Future Strategy To Up Revenue
• Effective product pricing strategy to gain
maximum market share.
• Develop strategic partnerships.
• Build a strong distribution channel.
• Increasing brand awareness among
healthcare professionals.
Market Insights
• The huge patient pool of anemia
in patients with CKD, boost the
player’s in the market.
• Key players are focusing on global
market share starting from China
than Europe, the U.S, Japan, India,
and the rest of the world
(Including Australia/New Zealand,
Southeast Asia, the Middle East,
and South Africa).
• Multiple players are in the
process of lunch the drug and
capture the market share.

10. THANK YOU