Suppliers and packagers for JESDUVROQ

JESDUVROQ

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Glaxosmithkline	JESDUVROQ	daprodustat	TABLET;ORAL	216951	NDA	GlaxoSmithKline LLC	0173-0897-13	30 TABLET, FILM COATED in 1 BOTTLE (0173-0897-13)	2023-02-01
Glaxosmithkline	JESDUVROQ	daprodustat	TABLET;ORAL	216951	NDA	GlaxoSmithKline LLC	0173-0903-13	30 TABLET, FILM COATED in 1 BOTTLE (0173-0903-13)	2023-02-01
Glaxosmithkline	JESDUVROQ	daprodustat	TABLET;ORAL	216951	NDA	GlaxoSmithKline LLC	0173-0906-13	30 TABLET, FILM COATED in 1 BOTTLE (0173-0906-13)	2023-02-01
Glaxosmithkline	JESDUVROQ	daprodustat	TABLET;ORAL	216951	NDA	GlaxoSmithKline LLC	0173-0911-13	30 TABLET, FILM COATED in 1 BOTTLE (0173-0911-13)	2023-02-01
Glaxosmithkline	JESDUVROQ	daprodustat	TABLET;ORAL	216951	NDA	GlaxoSmithKline LLC	0173-0914-13	30 TABLET, FILM COATED in 1 BOTTLE (0173-0914-13)	2023-02-01

Suppliers for the Pharmaceutical Drug Jesduvroq: A Comprehensive Analysis

The pharmaceutical landscape for anemia treatment in chronic kidney disease (CKD) patients has evolved significantly with the introduction of hypoxia-inducible factor prolyl hydroxylase inhibitors (HIF-PHIs). Jesduvroq (daprodustat), developed by GlaxoSmithKline (GSK), emerged as a pioneering oral therapy in this domain. This report examines the global supplier network for Jesduvroq, analyzing its regulatory journey, market availability, pricing dynamics, and regional accessibility challenges. The analysis incorporates recent developments, including GSK’s strategic withdrawals and the competitive responses from alternative therapies.

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Regulatory Approval and Market Authorization

FDA Approval and Initial U.S. Launch

Jesduvroq received U.S. Food and Drug Administration (FDA) approval on February 1, 2023, for treating anemia in CKD patients on dialysis for at least four months[1][3][5]. As the first oral HIF-PHI approved in the U.S., it offered a novel alternative to injectable erythropoiesis-stimulating agents (ESAs). The approval was based on the ASCEND-D trial, which demonstrated non-inferiority in cardiovascular outcomes compared to ESAs[3][7]. However, the drug carried a boxed warning for increased risks of mortality, myocardial infarction, stroke, and thrombosis[5][7].

Withdrawal from the U.S. Market

In December 2024, GSK withdrew Jesduvroq from the U.S. market for business reasons unrelated to safety or efficacy[2]. This decision reshaped the supplier ecosystem, leaving Akebia’s vadadustat (Vafseo) as the primary HIF-PHI alternative[2][4]. GSK’s exit underscores the challenges of commercializing oral anemia therapies in a market dominated by biologic ESAs and iron supplements.

International Regulatory Status

• Japan: Marketed as Duvroq by Kyowa Kirin, daprodustat has been available since June 2020 and remains a preferred HIF-PHI[1][9].
• Europe: Despite a positive opinion from the European Medicines Agency (EMA) in 2023, GSK abandoned plans to launch Jesduvroq in Europe, citing limited market potential and exclusion of non-dialysis patients from the label[9]. Competitors like roxadustat (Evrenzo) and vadadustat now dominate the region[9].
• India: Jesduvroq is not officially registered but accessible via named patient programs facilitated by suppliers like Alleviare India and Lucknow Speciality Pharma[6][10][12].

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Regional Supplier Networks and Access Channels

United States (Pre-Withdrawal)

GSK directly supplied Jesduvroq to U.S. pharmacies, with a wholesale acquisition cost (WAC) averaging $700 per 30-day supply[4]. Post-withdrawal, residual stock may remain available through specialty pharmacies, though Akebia’s Vafseo ($1,278 per 30-day supply) has positioned itself as the successor[4].

Japan

Kyowa Kirin distributes Duvroq nationwide, leveraging Japan’s early adoption of HIF-PHIs for both dialysis and non-dialysis CKD populations[1][9]. The drug’s market leadership reflects Japan’s regulatory flexibility and physician preference for oral therapies.

Europe

With GSK’s exit, Astellas (marketing roxadustat) and Akebia (vadadustat) serve as primary suppliers. Roxadustat’s broad label for non-dialysis patients gives it a competitive edge, though sales remain modest[9].

Emerging Markets: India and Neighboring Regions

Indian patients rely on specialized suppliers due to Jesduvroq’s unregistered status:

1. Alleviare India: Facilitates imports under the Named Patient Program, requiring a valid prescription, diagnostic reports, and an import permit[6]. Pricing varies based on dosage and import fees[6][12].
2. Lucknow Speciality Pharma: Offers Jesduvroq across major Indian cities, including Delhi, Mumbai, and Kolkata, with logistical support for documentation[10].
3. Indian Pharma Network: Provides competitive pricing and collaborates with international distributors to ensure authenticity[12].

These suppliers operate under GDP certification and prioritize compliance with local regulations, though costs remain higher than U.S. prices due to import taxes[6][10][12].

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Pricing Dynamics and Cost Considerations

U.S. Pricing (Before Withdrawal)

• 1 mg tablets: ~$131.71 for 30 tablets ($4.39/unit)[8].
• 8 mg tablets: ~$254.17 for 30 tablets ($8.47/unit)[8].

GSK’s pricing reflected its first-mover advantage, though Akebia’s post-withdrawal Vafseo pricing ($15,500 annually) highlights inflationary pressures tied to the Inflation Reduction Act[4].

International Cost Variability

• Japan: Duvroq’s pricing is undisclosed but competitively positioned given its market dominance[9].
• India: Jesduvroq costs approximately ₹10,000–₹15,000 per month, influenced by import duties and supplier margins[6][10].

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Regulatory and Market Challenges

Safety Concerns and Label Restrictions

Jesduvroq’s boxed warning for cardiovascular risks limited its appeal despite non-inferiority data[5][7]. The FDA’s cautious labeling—restricting use to dialysis patients—contrasted with Japan’s broader approval, illustrating regulatory divergences[7][9].

Competitive Pressures

The HIF-PHI class faces skepticism due to safety controversies. FibroGen’s roxadustat, rejected by the FDA in 2021, found success in Europe and China, while Akebia’s vadadustat struggles for traction[9]. GSK’s withdrawal reflects a strategic pivot away from high-risk markets.

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Future Outlook and Supplier Strategies

The anemia treatment market remains bifurcated:

1. Established Markets: Biologic ESAs retain dominance due to physician familiarity, though oral HIF-PHIs may gain ground with long-term safety data.
2. Emerging Markets: Suppliers like Alleviare India will continue bridging access gaps for unapproved therapies, leveraging named patient pathways.

GSK’s retreat underscores the importance of pharmacoeconomic considerations and regulatory alignment in sustaining supplier networks. Future innovation may focus on combination therapies or next-generation HIF-PHIs with improved safety profiles.

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Key Takeaways

1. Jesduvroq’s U.S. withdrawal reshaped supplier dynamics, favoring Akebia’s Vafseo and biologic ESAs.
2. Specialized suppliers in India and similar markets enable access via named patient programs despite regulatory hurdles.
3. Pricing disparities reflect regional regulatory policies and market competition.
4. Safety concerns and label restrictions remain critical barriers for HIF-PHI adoption.

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FAQs

1. Can U.S. patients still access Jesduvroq after its withdrawal?
No. GSK discontinued distribution, though residual stock may exist in limited quantities[2].

2. What alternatives exist for dialysis-dependent CKD patients in the U.S.?
Akebia’s Vafseo and traditional ESAs are the primary options[2][4].

3. How do Indian suppliers ensure Jesduvroq’s authenticity?
Reputable suppliers like Alleviare India source directly from manufacturers and require documentation to verify legitimacy[6][12].

4. Why did GSK withdraw Jesduvroq from Europe?
Limited market potential and exclusion of non-dialysis patients from the EMA’s recommendation[9].

5. What is the long-term outlook for oral HIF-PHIs?
Success depends on resolving safety concerns and demonstrating cost-effectiveness versus biologics[9].

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“Anaemia of CKD can be a debilitating condition that is challenging to manage. This news means that patients on dialysis who are living with anaemia of CKD now have another treatment option to help manage their anaemia.” – LaVarne Burton, American Kidney Fund[1]

References

1. https://www.gsk.com/en-gb/media/press-releases/jesduvroq-daprodustat-approved-by-us-fda-for-anaemia-of-chronic-kidney-disease-in-adults-on-dialysis/
2. https://www.empr.com/news/gsk-withdraws-jesduvroq-from-the-us-market/
3. https://www.pharmaceutical-technology.com/news/fda-gsk-anaemia-ckd/
4. https://www.fiercepharma.com/pharma/akebia-ends-csl-collab-kidney-disease-drug-vafseo-unveils-ira-driven-price-tag
5. https://www.drugs.com/history/jesduvroq.html
6. https://alleviareindia.com/jesduvroq-daprodustat-price-india/
7. https://www.drugdiscoverytrends.com/fda-greenlights-jesduvroq-which-gsk-hails-as-first-innovative-medicine-for-anemia-in-three-decades/
8. https://www.drugs.com/price-guide/jesduvroq
9. https://www.fiercepharma.com/pharma/gsk-scraps-plan-launch-oral-anemia-drug-eu-ceases-further-expansion
10. https://lucknowpharma.com/product/jesduvroq-daprodustatn-get-access-in-india/
11. https://www.clinicaltrialsarena.com/projects/jesduvroq-daprodustat-for-the-treatment-of-anaemia-of-chronic-kidney-disease-on-dialysis-usa/
12. https://www.indianpharmanetwork.in/jesduvroq-daprodustat/