While antimicrobial resistance is on the rise, more people continue to succumb to infections caused by drug-sensitive bacteria.
This shows that the continued progression of drug resistance is inevitable, due to giant populations of pathogens and their exposure to antibiotics. In addition, the researchers say, opportunistic pathogens will continue to endanger patients with weakened immune systems, even if they are susceptible to existing ones. antibiotics based on clinical microbiology tests.
These problems are interconnected and are very likely to become more accentuated as the human population ages, becomes denser, and faces shocks such as wars, excessive weather events, or declining living standards.
Today, Inceptua Group, a global pharmaceutical company, announced the expansion of its cefiderocol early access program to reach eligible patients in Argentina, Chile, Colombia, Guatemala, Mexico and Panama. This initiative is in partnership with Shionogi
Cefiderocol is a small molecule cephalosporin siderophore antibiotic developed through Shionogi to treat severe Gram-negative infections. It enters the outer mobile membrane of Gram-negative pathogens through binding to ferric iron and is actively transported to bacterial mobiles. concentrations in the periplasmic space, where it inhibits the synthesis of the mobile wall.
Although cefiderocol is still approved for advertising use in Latin America, it has gained approval from the U. S. FDA. It was approved by the U. S. Department of Health in 2019, the European Medicines Agency (EMA) in 2020, and Japan’s Ministry of Health, Labor and Welfare in 2023.
Inceptua and Shionogi have been involved since 2020 to make cefiderocol available through an early access program, first in Europe and then expanding to Canada and the Asia-Pacific region. To date, only about 1,000 patients have gained access to cefiderocol through this program.
Early access programs, also known as Extended Access, Managed Access, Compassionate Use, and Designated Patient Provision, provide a compatible pathway to make available medicines for patients who have few or no treatment options or who have exhausted all other available treatments. in his country of residence.
In the United States, cefiderocol is indicated in patients 18 years of age and older for the treatment of confounding urinary tract infections (UTIs), as well as pyelonephritis and nosocomial and ventilator-acquired bacterial pneumonia (HABP/VABP), caused by vulnerable Gram bacteria. -negative microorganisms such as Escherichia coli, Klebsiella pneumoniae and Pseudomonas aeruginosa, among others.
Inceptua Early Access provides strategic advice, design, facilitation, and implementation of global early programs, distributing unlicensed medicines and other medicines around the world. In partnership with pharmaceutical and biotech companies, it has a global reach, allowing patients to obtain potentially life-saving medicines. offices in 8 countries and a global warehousing and distribution network and continues to provide promising medicines to patients.
Inceptua Clinical Trial Supply provides clinical trial origination services, adding sourcing, packaging, labeling, storage, and distribution of comparators. With more than 25 years of experience and global operations in Europe, North America, and Asia, Inceptua serves life sciences corporations of all sizes.
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