Advanced Generation Cephalosporin Approved by US FDA

Basilea achieves a breakthrough with the US FDA approval for a new therapy for the treatment of severe infections, the first by the FDA after more than 15 years.

Highlights:

Basilea’s Zevtera gets U.S. FDA approval for MRSAB and other severe infections
Zevtera – A New antibiotic therapy for antimicrobial-resistant infections (AMR), especially those caused by methicillin-resistant Staphylococcus aureus (MRSA)
This U.S. FDA approval after more than 15 years will be a boost for other pharmaceutical companies

The U.S. Food and Drug Administration (FDA) granted approval to Basilea Pharmaceutica International Ltd. for the use of Zevtera (ceftobiprole medocaril sodium for injection) in serious bacterial infections in adults and pediatrics.

The three major indications and the target patients include:

Adults with Staphylococcus aureus bloodstream infections (bacteremia) (SAB)
Adults with acute bacterial skin and skin structure infections (ABSSSI)
Adult and pediatric patients (spanning from three months to less than 18 years old) with community-acquired bacterial pneumonia (CABP)

Peter Kim, M.D., M.S., director of the Division of Anti-Infectives in the FDA’s Center for Drug Evaluation and Research emphasized the important work being done by the U.S. FDA for public health and said, “The FDA is committed to fostering new antibiotic availability when they prove to be safe and effective, and Zevtera will provide an additional treatment option for a number of serious bacterial infections,”

MRSA “Super bug” – Symptoms - Risk Factors – Diagnosis - Treatment
MRSA infection is the most dreaded hospital or community acquired infection that can become life-threatening.

‘Basilea achieves FDA approval for Zevtera – a new therapy to treat severe infections - the first in over 15 years. #staphyllococcusinfections #FDA #Zevtera #medindia’

As per the news published by GlobalData, a leading data and analytics company, “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” ().

Zevtera: A Critical Role in MRSA and MSSA

Ceftobiprole medocaril sodium is a fifth-generation cephalosporin antibacterial effective against both Gram-positive and Gram-negative pathogenic organisms.

The approval of Zevtera is important as it includes treatment for antimicrobial-resistant infections (AMR), especially those caused by methicillin-resistant Staphylococcus aureus (MRSA). It is also effective against methicillin-susceptible Staohylococcus aureus (MSSA).

Antibiotic Resistance - An Emerging Global Crisis
Antibiotic resistance refers to the adaption of bacteria that allows them to grow even in the presence of antibiotics. The infection by the resistant bacteria are difficult to treat.

A Senior Pharma analyst at GlobalData, Nancy Jaser, PharmD/MBA commented, “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.”

Jaser also expressed that government actions are needed to provide profit-driven causes to pharmaceutical companies to secure the development of new antimicrobial therapies.

Staphylococcus Aureus Hacks the Immune System, Turns It Against the Body
Around 20 percent of us are constantly colonized by Staphylococcus aureus , bacteria that causes skin infections and is a major contributor to hospital infections

Boost for the Pharmaceutical Companies

FDA granted a market exclusivity of 10 years for Zevtera, this would be a significant prospect for Basilea to earn revenue.

Jaser concluded the report by stating. “If proper governmental incentives such as an ASB (Antibiotic Susceptibility Bonus) 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.”

Bacteremia - Causes, Symptoms, Diagnosis, Treatment, Prevention
Bacteremia is the presence of viable bacteria in the bloodstream. Blood cultures are used in diagnosis and antibiotics are used to treat bacteremia.

This approval highlights the importance of Zevtera in meeting the critical needs of patients and enhancing patient outcomes. Furthermore, the FDA approval should encourage pharmaceutical companies to develop new antimicrobial therapies, while providing a significant boost to the industry.

Reference:

FDA Approves New Antibiotic for Three Different Uses - (https://www.fda.gov/news-events/press-announcements/fda-approves-new-antibiotic-three-different-uses)

Source-Medindia