(AOF) – Guerbet recently submitted an NDA (New Drug Application, marketing authorization request) to the US Food and Drug Administration (FDA), as well as a centralized marketing authorization request to the European Agency (EMA) for Gadopiclenol, an investigational gadolinium-based macrocyclic contrast agent. These dossiers were accepted for evaluation on February 24 by the EMA and on March 28 by the FDA. In addition, the FDA has accepted the request for priority review, which commits it to rule on the file by September 21.
Priority review status is granted to applications for drugs that offer significant improvements in safety and efficacy in treating, diagnosing, or preventing serious disease over existing treatments.
The submissions are supported by data from two Phase III studies of the investigational gadolinium-based macrocyclic contrast agent Gadopiclenol, which were completed in March 2021.
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Boost for French pharmacy
At the end of a recent CSIS, the French authorities announced an amount of credits (7 billion euros) never reached: 1.5 billion for hospital-university research, 2 billion for investment in health via bpi france , 1.5 billion in aid for the relocation of industrial projects, and 2 billion to strengthen investment in three sectors of the future (bioproduction, digital medicine, and pandemic preparedness). In addition, the annual growth in drug expenditure reimbursed by Medicare will be 2.4%, which should generate growth of at least 0.5% in the turnover of laboratories,
Above all, the normal drug marketing procedure will be accelerated (up to 500 days saved) if the medical benefit rendered is sufficient.