Guerbet Introduces a Novel Injection to Identify CNS Abnormalities
Guerbet has recently announced the official launch and initial patient dosing of Elucirem™ (gadopiclenol) injection, following its FDA approval in September 2022. This groundbreaking macrocyclic gadolinium-based contrast agent (GBCA) offers superior relaxivity, making it highly suitable for magnetic resonance imaging (MRI) applications.
Elucirem™ is recommended for use in adults and children aged 2 years and above. Notably, it requires only half the gadolinium dose of conventional non-specific GBCAs, effectively addressing concerns among healthcare practitioners regarding gadolinium exposure. The first patient was successfully dosed at the University of Pennsylvania Hospital in Philadelphia, Pennsylvania.
The primary purpose of Elucirem™ (Gadopiclenol) injections is to facilitate the identification and visualization of lesions with abnormal vascularity in various regions of the body, including the central nervous system (brain, vertebrae, and related tissues), as well as the head and neck, thorax, abdomen, pelvis, and musculoskeletal system.
The FDA approval of Elucirem™ (NDA 216986) came after a priority review, a special designation granted to drug applications that offer significant improvements in safety or efficacy compared to existing therapies for the treatment, diagnosis, or prevention of serious conditions.
GBCAs, through their interaction with gadolinium atoms, expedite proton relaxation, leading to enhanced contrast between lesions and adjacent tissues. Elucirem's active ingredient, gadopiclenol, has been specifically engineered to enable twice as much interaction, resulting in the highest relaxivity among non-specific GBCAs. This unique property allows for the production of high-quality images using only half the standard amount of gadolinium.
Elucirem™ is manufactured by Liebel-Flarsheim™ Company LLC, a member of the Guerbet Group, located in Raleigh, North Carolina.
With the commercial availability of Elucirem™, Guerbet aims to revolutionize diagnostic imaging by providing a highly effective and safer contrast agent that can significantly improve patient outcomes and advance the field of MRI.
.This makes it possible to produce high-quality images using half the usual amount of gadolinium.
In Raleigh, North Carolina, the Liebel-Flarsheim™ Company LLC, a member of the Guerbet Group, produces Elucirem.