EL SEGUNDO, Calif., Aug. 3 /PRNewswire/ -- Computer Sciences Corporation today announced that the U.S. Food and Drug Administration has accepted DynPort Vaccine Company's (DVC) filing of a Biologics License Application for Vaccinia Immune Globulin (VIGIV), an intravenous immune globulin under evaluation for the treatment of adverse reactions to smallpox vaccination. DVC is a CSC company.
The application was submitted on May 21, 2004 and accepted for review on July 15, 2004. Acceptance for filing indicates recognition by the FDA that the submission is complete and warrants full review of the data needed to assess the quality, safety and efficacy of the therapeutic.
Cato Research Ltd., a global contract research and development organization headquartered in Research Triangle Park, NC, supported VIGIV's core development activities, including regulatory strategy, interactions with the FDA, preparation and review of the application, and manufacturing compliance matters.
VIGIV was manufactured from plasma donations of military personnel previously vaccinated with vaccinia, the virus used to vaccinate against the smallpox virus. The therapeutic contains purified antibodies specific to the vaccinia virus that assist in recovery of persons suffering from rare complications of vaccination against smallpox. VIGIV might be used in cases of generalized vaccinia, eczema vaccinatum or progressive vaccinia.
"This submission marks a major milestone in DVC's history," said DVC President Terry Irgens. "Vaccinia Immune Globulin is expected to be the company's first licensed product. This tremendous accomplishment would not have been possible without the support of the Department of Defense Joint Vaccine Acquisition Program and our many excellent subcontractors. VIGIV will provide additional reassurance that adequate treatment for complications of smallpox vaccinations is immediately available."
DVC is a biopharmaceutical company dedicated to the development and licensure of safe and efficacious biodefense vaccines for the Department of Defense and civilian populations. DVC is part of CSC's Enforcement, Security and Intelligence organization, which CSC created in 2002 to support programs enhancing U.S. security.
This product has not been approved by the FDA.
Founded in 1959, Computer Sciences Corporation is a leading global information technology (IT) services company. CSC's mission is to provide customers in industry and government with solutions crafted to meet their specific challenges and enable them to profit from the advanced use of technology.
With approximately 90,000 employees, CSC provides innovative solutions for customers around the world by applying leading technologies and CSC's own advanced capabilities. These include systems design and integration; IT and business process outsourcing; applications software development; Web and application hosting; and management consulting. Headquartered in El Segundo, Calif., CSC reported revenue of $14.8 billion for the 12 months ended April 2, 2004. For more information, visit the company's Web site at http://www.csc.com/.
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