Guerbet’s Elucirem Approved by FDA for Contrast-Enhanced MRI

September 27, 2022—Guerbet recently announced that Elucirem (gadopiclenol) was approved by the FDA after a priority review. Elucirem is a new macrocyclic gadolinium-based contrast agent (GBCA) with high relaxivity indicated for use in adults and children aged ≥ 2 years for contrast-enhanced MRI.

According to the company, the product is used to detect and visualize lesions with abnormal vascularity in the central nervous system (brain, spine, associated tissues) and the body (head and neck, thorax, abdomen, pelvis, musculoskeletal system).

Gadopiclenol, the active substance of Elucirem, has been designed with two sites for water molecule exchange to increase relaxivity and contrast, allowing for use at half the conventional dose of gadolinium compared to other nonspecific GBCAs.

The company advised that the efficacy and safety of gadopiclenol have been assessed as part of Guerbet’s clinical development plan, with marketing authorization being targeted worldwide.

The FDA is the first health regulatory authority to approve Elucirem. Elucirem is currently in the process of examination by the European Medicines Agency via a centralized procedure.

The approval was primarily based on data from two phase 3 studies (PICTURE and PROMISE) completed in March 2021 that demonstrated that Elucirem led to noninferior results in brain and body MRI at half the gadolinium dose of gadobutrol.

The studies’ endpoints were met in terms of the diagnostic benefit of injecting gadopiclenol (0.05 mmol/kg) during MRI examinations based on two criteria: the superiority of the examination with gadopiclenol compared to the examination with no contrast agent and the noninferiority of gadopiclenol (0.05 mmol/kg) compared to gadobutrol (0.1 mmol/kg) for the visualization and detection of lesions of the central nervous system and in the other anatomica areas studied.

No major safety signals were reported during the development of gadopiclenol, and the adverse reactions reported during the two phase 3 studies were similar for both products administered.

The press release further noted that in December 2021, Guerbet and Bracco Imaging entered into a worldwide collaboration on gadopiclenol manufacturing and research and development. Gadopiclenol will be commercialized independently under separate brands. Both Guerbet and Bracco Imaging each own valuable intellectual property on gadopiclenol. Furthermore, after an agreed transition period when Guerbet manufactures gadopiclenol for both Guerbet and Bracco Imaging, both companies will manufacture gadopiclenol active ingredient and finished product.