Jerusalem-based Rafa Laboratories LTD. (“Rafa“) is pleased to announce the U.S. Food and Drug Administration has approved its “first in market” 10 mg midazolam autoinjector for the treatment of status epilepticus in adults. As such, this new AAS (Advanced Anticonvulsant System) 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 development of the product is yet another fruitful cooperation between Rafa and the U.S. Department of Defense’s (DOD) Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense (JPEO-CBRND), having previously collaborated on the development of Rafa‘s Atropine autoinjector that was launched in the U.S. in 2017. The DOD’s Chemical and Biological Defense Program also supported this effort.
The midazolam injection autoinjector was already under development at Rafa when collaborations with Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense (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.”
The Midazolam 10 mg autoinjector is indicated for the treatment of status epilepticus, or prolonged seizures, in adults. As such, this new autoinjector can be used to treat seizures resulting from nerve agent exposure. According to the U.S. JPEO-CBRND, the autoinjector improves upon and will replace the currently fielded convulsant antidote for nerve agent (CANA) diazepam autoinjector.
FDA approval was obtained following an expedited review, a testament to the importance and urgent need of the product, with NDA submission and final approval achieved in less than five months through prioritized engagement between the U.S. DOD and the FDA. According to guidelines of the American Epilepsy Society, Midazolam Intra-muscular is a first-line therapy for Status Epilepticus.
Rafa‘s innovation resides in the use of an autoinjector to be administered intramuscularly to the thigh (can be administered through clothes as well), in a simple and fast manner that does not require an intravenous line. This is a significant advantage in a field setting during an emergency when fast treatment reduces the likelihood of permanent damage that could result from a continuous seizure.
The product was developed in Israel and is manufactured at Rafa’s manufacturing site in Jerusalem.
It is already sold under EUA (Emergency Use Authorization) in other territories and is an important addition to Rafa’s current autoinjector portfolio, which includes various formulations for emergency use.
Amir Levin, CEO of Rafa, stated: “We are proud of the FDA approval for this life saving product. It is made in Israel and is meaningful news to the world of medical emergency solutions, thus strengthening Rafa’s key role in providing reliable products to armies, governments, and first responders worldwide.”
Roy Shay, Head of Emergency Solutions at Rafa, commented: “The usability of the autoinjector has a significant medical advantage in its immediate treatment effect, as well as in reducing long-term damage. Clinical studies confirmed the correlation between early treatment of status epilepticus and a reduced risk of ongoing and irreversible neurological damage. This product could assist in saving many lives around the globe.”
Founded in 1937 and headquartered in Jerusalem, Israel, Rafa is among the leading pharmaceutical companies in Israel and a global player in emergency solutions – medical countermeasures, supplying auto-injectors for government agencies, military forces, and civilian populations. Rafa‘s competencies span the entire value chain from R&D and manufacturing by international standards (e.g. FDA, EMA) all the way through sales and marketing. With a proven track record of successful commercialization of niche and orphan products, Rafa has been privileged to nurture long-lasting alliances with leading innovative companies such as United Therapeutics, Helsinn, Zambon, Galderma, Dr. Falk, and Mundipharma, in a variety of therapeutic areas including oncology, hematology, respiratory, gastroenterology, and dermatology. Rafa‘s controlling shareholder, FIMI Opportunity Funds, is the leading private equity fund in Israel with a track record of success spanning over 25 years and assets under management of $7b. Since its inception, FIMI’s performance has been exceptional by both local and global standards after having completed close to 100 investments.”
For additional information, please contact:
Roy Shay, Head of Emergency Solutions at Rafa, roys AT rafa.co.il
Source: Cision PR Newswire
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