💡 Cefiderocol: Tackling resistant Gram-negative infections & bridging access gaps 🌏

AMR is continuing to spread, but so are new models for access. Cefiderocol shows what the future of equitable antibiotics could look like.

As antimicrobial resistance continues to accelerate, particularly among carbapenem-resistant Gram-negative bacteria, cefiderocol has emerged as one of the most important new antibiotics of the past decade. Developed by Shionogi, cefiderocol is a siderophore-conjugated cephalosporin that exploits bacterial iron-uptake systems to reach the periplasm and inhibit penicillin-binding proteins. Equally important is the way it is becoming increasingly available worldwide.

🌍 While cefiderocol is currently available in Japan, the USA, the EU, and Taiwan, Shionogi’s partnership with GARDP and Orchid Pharma will reshape what equitable antibiotic access can look like.

🤝 In short, GARDP holds the licence to supply cefiderocol across 135 countries, including most low- and middle-income nations. Orchid Pharma (India) will manufacture an affordable generic version via technology transfer and a cost-plus pricing model. The goal: ensure that countries carrying the highest AMR burden aren’t the last to receive new antibiotics. More information: GARDP video and Shionogi’s website.

💊 What’s happening in Australia? An NDA for cefiderocol was accepted by the TGA in December 2024 and remains under evaluation. In April 2025, Shionogi announced an exclusive licensing agreement with Link Healthcare for development and commercialisation in Australia and New Zealand. In the interim, cefiderocol is accessible via the TGA Special Access Scheme (SAS), with 49 requests in 2023 (see 30 July FOI disclosure).

🌟 Why This Matters

◆ Cefiderocol’s story isn’t just about a new antibiotic. It’s about building sustainable, equitable pathways to ensure life-saving AMR tools reach every region that needs them—not only high-income markets. ✔️

◆ Innovative access models like this could become the blueprint for future global preparedness against AMR. 🎯

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