Inceptua Group Expands Early Access Programme to Latin America
May 15, 2024 – Clinical Trials, Drug Delivery, Logistics – Early Access Programme, Inceptua, Shionogi, cUTIs
15 May 2024 — Luxembourg — Inceptua, a global pharmaceutical service company, announces an expansion of an Early Access Programme for cefiderocol for eligible patients in Argentina, Chile, Colombia, Guatemala, Mexico and Panama. In partnership with Shionogi & Co, and the approval from and in accordance with local regulatory authorities, Shionogi will supply US-labelled cefiderocol through the Inceptua Early Access Programme on a case-by-case basis to patients outside of a clinical trial.
“Inceptua is pleased to announce the expansion of this Early Access Programme 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 Programme since 2020, starting initially in Europe, with subsequent expansions into Canada and the Asia Pacific region. The programme has provided access to cefiderocol for nearly 1,000 patients to date.
Early Access Programmes (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 US, 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 US 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 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 programmes, and distributes unlicensed and other medicines worldwide, Inceptua Early Access partners with pharma and biotech companies to provide truly global early access programmes, 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.
