2024-03-25 07:50:00
Pfizer receives positive CHMP opinion for the new antibiotic combination EMBLAVEO
Pfizer announced that Il Committee for Medicinal Products for Human Use (CHMP) ofEuropean Medicines Agency (EMA) has adopted a positive opinion regarding the placing on the market for EMBLAVEO® (aztreonam-avibactam) in the treatment of adult patients with complicated intra-abdominal infections (cIAI), hospital-acquired pneumonia (HAP), including ventilator-associated pneumonia (VAP), and complicated urinary tract infections (cUTI), including pyelonephritis.
If approved, the drug will also be indicated for the treatment of infections caused by aerobic Gram-negative microorganisms in adult patients with limited therapeutic options. There marketing authorization application (MAA) was examined according to the accelerated assessment procedure, used by the CHMP when a pharmaceutical product is of great interest for public health and therapeutic innovation.
“Gram-negative bacteria are often resistant to multiple drugs, leaving infected patients severely ill and at high risk for serious complications, including mortality“, he has declared To James RusSenior Vice President e Chief Development Officer, Internal Medicine, Anti-Infectives and Hospital, Pfizer. “If approved, aztreonam-avibactam could offer hope to adult patients with life-threatening Gram-negative bacterial infections, who currently have limited treatment options. This recommendation is a positive step for patients with Gram-negative infections that are resistant to nearly all available antibiotics and demonstrates Pfizer’s commitment to helping address the global public health threat of antimicrobial resistance“.
The antibiotic resistance (AMR), particularly in Gram-negative bacteria, is a major threat to global health, and the development of new treatments for infections caused by these bacteria has been highlighted as a key area byWorld Health Organization (WHO). A continued increase in antibiotic resistance could lead to 10 million deaths per year worldwide by 2050, and an estimated 1.27 million deaths globally were caused by bacterial antibiotic resistance in 2019 alone. Without solutions, the continued rise of antibiotic resistance could make routine medical procedures too risky.
The marketing authorization for aztreonam-avibactam include i positive results from the Phase 3 study program previously reported, including the REVISIT (NCT03329092) and ASSEMBLE (NCT03580044) studies, which evaluated the efficacy, safety and tolerability of the drug in the treatment of serious bacterial infections due to Gram-negative bacteria, including multidrug-resistant metal-producing pathogens -β-lactamases (MBL) for which therapeutic options are limited or absent. The data confirm that aztreonam-avibactam is effective and well tolerated, with no new safety findings and with a safety profile similar to that of aztreonam alone aztreonam.
The European Commission (EC), which grants centralized marketing authorizations in theEuropean Union (EU), will examine the recommendation of CHMP and is expected to make a final decision in the coming months. If granted, the centralized marketing authorization will be valid in all 27 EU member states, as well as in Iceland, Liechtenstein and Norway. Marketing authorization applications for aztreonam-avibactam are also expected to be submitted in other countries.
About EMBLAVEO® (aztreonam-avibactam)
If approved, aztreonam-avibactam will be indicated for the treatment of adult patients with complicated intra-abdominal infections (cIAI), hospital-acquired pneumonia (HAP), including ventilator-associated pneumonia (VAP), complicated urinary tract infections (cUTI), including pyelonephritis, and infections due to aerobic Gram-negative organisms with limited treatment options. The drug combines aztreonam, a monobactam β-lactam, with avibactam, a broad-spectrum β-lactamase inhibitor.
Metallo-β-lactamases (MBLs) are a class of β-lactam enzymes which are not inhibited by current β-lactamase inhibitors and hydrolyze almost all β-lactam antibiotics, with the exception of monobactams such as aztreonam. However, monobactams are degraded by other β-lactamases that are often co-produced with MBLs, limiting the clinical utility of aztreonam monotherapy.
The combination of aztreonam with avibactam restores aztreonam’s activity against bacteria that coproduce MBL and other β-lactamases and, if approved, could provide an effective and well-tolerated therapeutic option against multidrug-resistant Gram-negative bacteria. These multi-resistant Gram-negative bacteria include MBL-producing Enterobacterales, which has been highlighted as a priority critical pathogen by WHO, and Stenotrophomonas maltophilia.
If approved, it would be the first β-lactam/β-lactamase inhibitor combination for the treatment of severe bacterial infections caused by multidrug-resistant Gram-negative bacteria, including MBL-producing bacteria, approved for use in the EU. The drug was developed jointly with AbbVie. Pfizer holds the global rights to commercialize this investigational therapy outside the United States and Canada, where the rights are held by AbbVie. Its development has also been supported by public-private partnerships between Pfizer e U.S. Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA) under OTA number HHSO100201500029C, and through the EU Innovative Medicines Initiative (IMI) – a partnership between the EU and the European pharmaceutical industry, under a project called COMBACTE-CARE (Combating Bacterial Resistance in Europe – Carbapenem Resistance).
Il COMBACTE-CARE consortium is a first-of-its-kind public-private collaboration, combining the knowledge and skills of leading experts in drug-resistant bacterial infections and supported by pan-European clinical and laboratory networks FIGHT.
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