FDA Issues Emergency Use Authorization For Astrazeneca's Evusheld™ (Tixagevimab Co-packaged With Cilgavimab), The First Antibody Therapy Authorized In The U.S. For Pre-exposure Prophylaxis Of COVID-19
MIAMI, FL, Dec. 10, 2021 /PRNewswire/ -- Brand Institute is proud to announce its successful partnership with AstraZeneca in developing the brand name EVUSHELD™ and assisting with the development of the nonproprietary names tixagevimab and cilgavimab, together denoting the first long-acting antibody combination authorized for emergency use by the U.S. Food and Drug Administration (FDA) for pre-exposure prevention of COVID-19. EVUSHELD™ works specifically to protect adults and adolescents (aged 12 and older) with immune systems that have been compromised by a medical condition or immunosuppressive medications.
"The entire Brand Institute and Drug Safety Institute Team congratulates AstraZeneca on the emergency use authorization of EVUSHELD™ by the FDA," said Brand Institute's Chairman and CEO, James L. Dettore. "EVUSHELD™ will surely be an important treatment option in the global fight against COVID-19, especially for at-risk individuals whose immune systems are unable to generate a sufficient response to the disease on their own, even once vaccinated—as well as individuals for whom vaccination isn't recommended in the first place. The FDA's tentative authorization now allows the protection that EVUSHELD™ has been shown to provide to be put to work."
Full FDA approval of EVUSHELD™ may be granted once it undergoes complete review according to the FDA's guidelines, policies, and procedures.
About Brand Institute and our wholly owned subsidiary, Drug Safety Institute
Brand Institute is the global leader in pharmaceutical and healthcare-related name development, with a portfolio of over 3,500 marketed healthcare names for nearly 1,000 clients. The company partners on over 75% of pharmaceutical brand and nonproprietary name approvals globally every year. Drug Safety Institute is comprised of former naming regulatory officials from global government health agencies, including FDA, EMA, Health Canada, American Medical Association (AMA), and the World Health Organization (WHO). These regulatory experts co-authored the name review guidelines while with their respective agencies, with many responsible for ultimately approving (or rejecting) brand name applications. Now working for a private company, these professionals provide Brand Institute's clients with industry-leading guidance pertaining to drug name safety (i.e., preventing medication errors), packaging, and labeling.
Contact: Scott Piergrossi
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SOURCE Brand Institute, Inc.