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Inceptua Group Expands Early Access Program to Latin America
Luxembourg, May 15, 2024. Inceptua Group (Inceptua) – a global pharmaceutical service company – announces an expansion of an Early Access Program for cefiderocol for eligible patients in Argentina, Chile, Colombia, Guatemala, Mexico, and Panama. In partnership with Shionogi & Co. Ltd. and the approval from and in accordance with local regulatory authorities, Shionogi will supply U.S.-labeled cefiderocol through the Inceptua Early Access Program on a case-by-case basis to patients outside of a clinical trial.
“Inceptua is pleased to announce the expansion of this Early Access Program to Latin America to allow physicians the opportunity to access this medicine for use with appropriate patients with certain serious gram-negative bacterial infections,” says Stuart Bell, Executive Vice President, Inceptua Early Access.
Inceptua and Shionogi have been working together to make cefiderocol available to patients through an Early Access program since 2020, starting initially in Europe, with subsequent expansions into Canada and the Asia Pacific region. The program has provided access to cefiderocol for nearly 1,000 patients to date.
Early Access Programs (also known as expanded access, managed access, compassionate use, named patient supply) are a compliant route through which medicines that are either still under development or not approved in their country of intended use can be made available for patients who either have limited or no alternative treatment option or have exhausted all other treatment options available in their country of residence.
In the U.S., cefiderocol is indicated in patients 18 years of age or older for the treatment of complicated urinary tract infections (cUTIs), including pyelonephritis caused by the following susceptible gram-negative microorganisms: Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, and Enterobacter cloacae complex. Cefiderocol is also indicated in the U.S. in patients 18 years of age or older for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP), caused by the following susceptible gram-negative microorganisms: Acinetobacter baumannii complex, Escherichia coli, Enterobacter cloacae complex, Klebsiella pneumoniae, Pseudomonas aeruginosa, and Serratia marcescens.
About Cefiderocol
Cefiderocol for injection is a siderophore cephalosporin antibiotic for the treatment of serious gram-negative infections manufactured by Shionogi & Co. Ltd
It has a novel mechanism for penetrating the outer cell membrane of gram-negative pathogens by acting as a siderophore. In addition to entering cells by passive diffusion through porin channels, cefiderocol binds to ferric iron and is actively transported into bacterial cells through the outer membrane via the bacterial iron transporters, which function to incorporate this essential nutrient for bacteria. These mechanisms allow cefiderocol to achieve high concentrations in the periplasmic space where it can bind to penicillin-binding proteins and inhibit cell wall synthesis in the bacterial cells.
While not yet being approved for commercial use in Latin America, cefiderocol has received approval from the U.S. Food and Drug Administration (FDA) in 2019, the European Medicines Agency (EMA) in 2020, and the Japanese Ministry of Health, Labor, and Welfare in 2023.
Please click here* for Full U.S. Prescribing Information for cefiderocol.
About Inceptua
Inceptua is a global pharmaceutical services company with market-leading capabilities across multiple business areas such as Clinical Trial Supply and Early Access.
Inceptua Early Access offers strategic advice, design, facilitation, and implementation of global early access programs, and distributes unlicensed and other medicines worldwide, Inceptua Early Access partners with pharma and biotech companies to provide truly global early access programs, which allow patients around the world access to potentially life-saving medicines. With offices in 8 countries, and a global warehousing and distribution network, Inceptua Early Access is the preferred partner for many companies in their efforts to bring promising medicines to patients as quickly as possible.
Inceptua Clinical Trial Supply provides clinical trial supply, services, and logistics, including comparator sourcing of medicines, packaging, labelling, storage, and distribution services.
Inceptua has over 25 years of experience serving life science companies of all sizes, and has global operations with offices across Europe, North America and Asia.
Additional information is available at: www.inceptua.com.
For questions about the Early Access Program
Please contact Inceptua at access@inceptua.com or call +1-646-307-9770.
Inceptua Media Contact:
Morten Grøn
VP, Corporate Communication and Marketing
Telephone: +45 2556 4781
E-Mail: morten.gron@inceptua.com
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Conference attendance: Meet Inceptua Early Access & Unlicensed Medicines 2024