News | Contrast Media | April 06, 2022

Priority Review granted by US-FDA March 28, 2022

Guerbet, a global leader in medical imaging offering a comprehensive range of pharmaceutical products, medical devices, and digital and artificial intelligence (AI) solutions for diagnostic and interventional imaging, has recently submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) and a Centralized Application for Marketing Authorization to the European Medicine Agency (EMA) for Gadopiclenol, an investigational macrocyclic gadolinium-based contrast agent (GBCA).

April 6, 2022 — Guerbet, a global leader in medical imaging offering a comprehensive range of pharmaceutical products, medical devices, and digital and artificial intelligence (AI) solutions for diagnostic and interventional imaging, has recently submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) and a Centralized Application for Marketing Authorization to the European Medicine Agency (EMA) for Gadopiclenol, an investigational macrocyclic gadolinium-based contrast agent (GBCA). Those applications have been accepted for review by EMA and FDA on February 24 and March 28, respectively.

In addition, the US-FDA has accepted the request for Priority Review with a goal date for taking action on an application by September 21, 2022. Priority review designation is assigned to applications for drugs that provide significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions compared to available therapies.

The dossiers are supported by the data from two Phase III studies for the investigational macrocyclic GBCA, Gadopiclenol completed in March 2021. The results from these Phase III studies are available on the ClinicalTrials.gov database (see below).

About Gadopiclenol

Gadopiclenol is an investigational macrocyclic gadolinium-based contrast agent developed by Guerbet’s Research & Development team. The efficacy and safety of Gadopiclenol have been evaluated as part of the company’s clinical development plan with a view to obtaining worldwide marketing authorization. No regulatory authority has evaluated the clinical study data for this product to date. Details on Phase III clinical trials are available on the www.ClinicalTrials.gov.

• Efficacy and Safety of Gadopiclenol for Central Nervous System (CNS) Magnetic Resonance Imaging (MRI) - Full Text View - ClinicalTrials.gov

• Efficacy and Safety of Gadopiclenol for Body Magnetic Resonance Imaging (MRI) Full Text View -ClinicalTrials.gov

For more information: www.guerbet.com


Related Content

News | Radiology Business

July 9, 2024 — Bracco and Blue Earth Diagnostics, a Bracco company and recognized leader in the development and ...

Time July 09, 2024
arrow
News | Prostate Cancer

July 5, 2024 — Lantheus Holdings, Inc., a leading radiopharmaceutical-focused company committed to enabling clinicians ...

Time July 05, 2024
arrow
News | Prostate Cancer

July 2, 2024 — A new editorial paper was published in Oncoscience (Volume 11) on May 20, 2024, entitled, “Deep learning ...

Time July 02, 2024
arrow
News | ASTRO

June 21, 2024 — The American Society for Radiation Oncology (ASTRO) announced today that following a nationwide search ...

Time June 21, 2024
arrow
News | Nuclear Imaging

June 20, 2024 — GE HealthCare joined the world’s top medical and academic institutions at the Society of Nuclear ...

Time June 20, 2024
arrow
News | Proton Therapy

June 14, 2024 — Atlantic Health System, an integrated health care system setting standards for quality health care in ...

Time June 14, 2024
arrow
News | PET Imaging

June 14, 2024 — Positron Corporation, a leading molecular imaging medical device company offering PET and PET-CT ...

Time June 14, 2024
arrow
News | SNMMI

June 13, 2024 — The Society of Nuclear Medicine and Molecular Imaging (SNMMI) hosted more than 8,000 physicians ...

Time June 13, 2024
arrow
News | PET-CT

June 13, 2024 — Positron Corporation, a leading molecular imaging medical device company offering PET and PET-CT ...

Time June 13, 2024
arrow
News | Radiology Business

June 12, 2024 — Cathy Sue Cutler, PhD, FSNMMI, chair of the Isotope Research and Production Department at Brookhaven ...

Time June 12, 2024
arrow
Subscribe Now