ID:IOTS - Infectious Disease Insight Of Two Specialists 37. The Tragedy of Plazomicin
Dec 25, 2022
The rise and fall of Plazomicin reveals the harsh realities of antibiotic development. Explore the financial and regulatory hurdles that inhibit new antibiotic approvals. The innovative subscription model for pharmaceuticals may offer a solution, but what are the implications? Delve into the balance of cost and efficacy in antibiotic selection and the ongoing challenge of antibiotic resistance. The discussion emphasizes the importance of stewardship and invites listener support for reintroducing promising treatments like Plazomicin.
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What Plazomicin Is And Its Limits
- Jame explains plazomicin as a next-generation aminoglycoside designed to resist aminoglycoside-modifying enzymes.
- He notes its limited activity against Pseudomonas and no activity against Acinetobacter or Stenotrophomonas.
Achaogen's Rapid Rise And Fall
- Jame recounts Achaogen's FDA approval in 2018 and their rapid bankruptcy after only $1 million in first-year sales.
- He describes how narrow initial indications (complicated UTI) and low uptake sank the company financially.
Cipla's Purchase And EMA Roadblocks
- Jame describes Cipla buying plazomicin cheaply and then withdrawing its EMA application in 2020.
- He cites EMA concerns about pediatric trials and sterilization process requirements as the dealbreaker.