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NEWS | Aug. 24, 2022

FDA Approves New Drug Application for the DoD’s Advanced Anticonvulsant System Program

August 23, 2022 – The Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense’s (JPEO-CBRND) Joint Project Manager for Chemical, Biological, Radiological, and Nuclear Medical (JPM CBRN Medical) received notice of U.S. Food and Drug Administration (FDA) approval of Rafa Laboratories, Ltd.’s (Rafa) midazolam injection autoinjector New Drug Application (NDA). The Defense Department (DoD) developed the product with Rafa, via JPM CBRN Medical’s Advanced Anticonvulsant System (AAS) program team. The DoD’s Chemical and Biological Defense Program supported this effort.

The midazolam injection autoinjector is indicated for the treatment of status epilepticus, or prolonged seizures, in adults. As such, this new AAS autoinjector can be used to treat seizures resulting from nerve agent exposure. The AAS improves upon and will replace the currently fielded convulsant antidote for nerve agent (CANA) diazepam autoinjector. 

The midazolam injection autoinjector was already under development at Rafa when collaborations with JPM CBRN Medical began in August 2020. Approval of the AAS midazolam injection NDA was expedited through enhanced engagement under Public Law 115-92, with NDA submission and final approval achieved in less than five months through prioritized engagement between the DoD and the FDA. 

“This is a tremendous step forward to protect the warfighter from the effects of chemical agents we may encounter on the battlefield,” said Col. Matthew Clark, Joint Project Manager for CBRN Medical. “Strong partnerships and engagement with both the performer and the FDA demonstrate that together, we effectively deliver critical medical countermeasures to the warfighter and the nation. FDA approval of this life-saving drug and device combination product allows for safe and effective treatment of our service members in CBRN-contested environments, and greatly contributes to Joint Force readiness.”

About the JPM CBRN Medical: The Joint Project Manager for Chemical, Biological, Radiological, and Nuclear Medical (JPM CBRN Medical), a component of the U.S. Department of Defense’s Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense, aims to provide U.S. military forces and the nation with safe, effective, and innovative medical solutions to counter chemical, biological, radiological, and nuclear threats. The JPM CBRN Medical facilitates the advanced development and acquisition of medical countermeasures and systems to enhance the nation’s biodefense response capability. 

About the JPEO-CBRND: The Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) protects the Joint Force by providing medical countermeasures and defense equipment against chemical, biological, radiological and nuclear (CBRN) threats. The JPEO-CBRND’s goal is to enable the Joint Force to fight and win unencumbered by a CBRN environment. The JPEO-CBRND facilitates the rapid response, advanced development, manufacturing and acquisition of medical solutions, such as vaccines, therapeutics, and diagnostics, to combat CBRN and emerging threats such as COVID-19. To learn more about the JPEO-CBRND, visit https://www.jpeocbrnd.osd.mil or follow the JPEO-CBRND on social media at @JPEOCBRND.

 

JPEO-CBRND Press Kit

Download our press kit, which includes helpful documents to better understand our work, such as – Command Brief, Chemical Biological Defense Program's Enterprise strategy, the JPEO-CBRND's Capabilities Catalog, Leadership Biographies, COVID-19 fact sheets, and contracting overview documents.  

 

 


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