FDA
18th April 2014

AdComm Roll Call – Spotlight on: Medical Imaging Drugs Advisory Committee

The Medical Imaging Drugs Advisory Committee (MIDAC) is one of the FDA’s knowledgeable panels, charged with evaluating the safety and effectiveness of marketed.

AdComm Roll Call – Spotlight on: Medical Imaging Drugs Advisory Committee

The Medical Imaging Drugs Advisory Committee (MIDAC) is one of the FDA’s knowledgeable panels, charged with evaluating the safety and effectiveness of marketed and investigational human drug products for diagnostic and therapeutic procedures or radiology utilizing radioactive pharmaceuticals and contrast media. MIDAC is responsible for making appropriate recommendations to the Commissioner.

Medical imaging is the technique, process and art of creating visual representations of the inside of the body for clinical analysis and medical intervention as needed. Medical imaging seeks to reveal internal structures which lie beneath what the eyes can see, as well as to diagnose and treat disease that cannot be diagnosed from examining the outer body. Medical imaging also establishes a database of normal anatomy and physiology to make it possible to identify abnormalities. 

 

MIDAC met two times in 2013 and currently has no meetings scheduled for this year.

The first meeting of 2013 took place on Valentine’s Day, February 14th. During this meeting MIDAC met to discuss the new drug application (NDA) 204781, proposed trade name DOTAREM (gadoterate meglumine injection), produced by Guerbet, LLC. DOTAREM is intended for use in magnetic resonance imaging procedures of the brain (intracranial), the spine, and associated tissues. It is designed for use in both adults and pediatric patients (neonates to 17 years of age) to detect and visualize areas with disruption of the blood brain barrier (specialized tissues which help protect the brain) and/or abnormal blood circulation (identified by abnormal vascularity).

In this meeting, two discussion questions and one voting question were posed to the committee. The voting question had three parts pertaining to three different patient age groups. The panel voted unanimously for both adults and pediatric patients (greater than or equal to 2 years of age) that the “risk to benefit” profile was favorable for the use of gadoterate in CNS magnetic imaging. However, the majority of panelists (10 vs. 6, 1 abstention) voted that there was insufficient data to determine whether the “risk to benefit” profile was favorable in pediatric patients under 2 years of age. 

The second meeting took place on May 3rd, and was a joint meeting along with the Oncologic drugs Advisory Committee, During this meeting, the committees discussed the safety and efficacy of currently approved leukocyte growth factors (LGFs) as potential treatments for radiation-induced myelosuppression associated with a radiological/nuclear incident. The currently approved LGFs are licensed under biological license applications (BLAs) are NEUPOGEN (filgrastim, Amgen, Inc.), NEULASTA (pegfilgrastim, Amgen, Inc.), LEUKINE (sargramostim, Genzyme, Inc.), and TBO-FILGRASTIM (tbo-filgrastim, Sicor Biotech, UAB). Myelosuppression is a reduction of blood cell production, which can be caused by radiation exposure.

Also in this meeting, two discussion questions and one voting question were posed to the committee. The vote was almost unanimous. 17-1 panelists agreed that the drugs mentioned above (i.e. filgrastim therapy) are reasonably likely to produce clinical benefits in humans exposed to radiation (likely to induce myelosuppression) during or following a radiological/nuclear incident. This meeting was unique as the supporting studies were completed in primates and approval for this indication was under the relatively new Animal Rule. Innovative Science Solutions was pleased to be involved with the preparations for this meeting and has also been involved with the two prior meetings which focused on this unique approval pathway.

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ISS has over a decade of experience in developing regulatory strategies including support for FDA Advisory Committee meetings. We are involved in more FDA AdComms per year than even the largest pharmaceutical companies. For more information on how ISS can help you prepare for your next meeting, contact info@innovativescience.net.

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