GlobalData : Basilea’s Zevtera will play unique yet critical role in MRSAB as first new therapy to gain FDA approval in over 15 years, says GlobalData

12 Apr, 2024 Basilea's Zevtera will play unique yet critical role in MRSAB as first new therapy to gain FDA approval in over 15 years, says GlobalData

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The FDA has approved Basilea Pharmaceutica's advanced generation cephalosporin antibiotic, Zevtera (ceftobiprole medocaril), for the treatment of three major indications: Staphylococcus aureus bacteremia (SAB), including right-sided infective endocarditis, acute bacterial skin and skin structure infections (ABSSSI), and community-acquired bacterial pneumonia (CABP). As the first drug to reach the US market for the treatment of SAB in over 15 years, Zevtera will play a unique and critical role in the future management of this serious, and commonly fatal infection, says GlobalData, a leading data and analytics company.

Zevtera's approval is significant as it covers antimicrobial-resistant (AMR) infections, notably those caused by methicillin-resistant Staphylococcus aureus (MRSA). The fifth-generation cephalosporin also exhibits antibacterial activity against a wide range of both Gram-positive and Gram-negative pathogens, further showcasing its broad clinical utility. This makes Zevtera an attractive empiric monotherapy for infections where MRSA is suspected, but Gram-negative coverage is also warranted.

Nancy Jaser, PharmD/MBA, Senior Pharma Analyst at GlobalData, comments: "Given the alarming lack of therapeutic options for MRSA in deadly infections such as SAB (MRSAB), Zevtera should be strictly reserved for serious multi-drug resistant cases that cannot be successfully treated with current therapies. This limitation will be critical for minimizing treatment-emergent resistance to Zevtera and maintaining its efficacy."

However, it is crucial to ensure that Basilea can generate sufficient profits, despite deliberately low drug sales, to keep Zevtera on the market.

Jaser continues: "Improved governmental actions to realign the profit-based incentives of pharmaceutical companies with larger antibiotic preservation efforts are urgently needed to salvage the future of new antimicrobial development."

Key opinion leaders (KOLs) interviewed by GlobalData noted that AMR is an increasingly serious issue as more pharmaceutical companies are losing interest in the antibiotic space.

A promising mechanism proposed by the World Health Organization (WHO) involves implementing a large financial incentive known as the antibiotic susceptibility bonus (ASB) to developers if resistance to their drug remains low over a specified period. This strategy would incentivize Basilea to keep sales at a minimum, aligning its goals with those of antibiotic stewardship programs across the US.

Zevtera was granted 10 years of market exclusivity upon approval. Such a win would typically be viewed as a major opportunity for revenue growth, particularly as the US represents a large proportion of the global antibiotics market. Similarly, antibiotic stewardship efforts and concerns about treatment-emergent resistance would be seen as a threat to sales, limiting the use of Zevtera as a front-line option for suspected MRSA infections.

Jaser concludes: "If proper governmental incentives such as an ASB are put into action, antibiotic developers and public health groups would be working towards the same goal, limiting failures for both parties and greatly improving the future outlook for tackling AMR."

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