Global InformationRemune information
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Remune was the first therapeutic HIV vaccine based on the killed whole virus approach. Remune was initially invented by Jonas Salk in 1987 and was developed by Immune Response BioPharma, Inc. (IRBP) [1]
Remune is a therapeutic HIV/AIDS vaccine that has completed over 25 clinical studies to date and shows a robust mechanism of action restoring white blood cell counts in CD4 and CD8 T cells by reducing viral load and increasing immunity.
The FDA is currently reviewing IRBP’s BLA (biologics licensing application) for therapeutic treatment in people with HIV. Once the FDA approves the BLA, Remune will be the first therapeutic HIV vaccine brought to market.[2]
IRBP is set to submit its BLA with the FDA in early 2014. REMUNE granted FDA Pediatric Orphan Designation on Feb 14th 2014.[3]
- ^ Immune Response BioPharma, Inc
- ^ http://www.prlog.org/12440202-immune-response-biopharma-inc-announces-the-fda-has-accepted-remune-hivaids-vaccine-bla-for-review.html
- ^ "Search Orphan Drug Designations and Approvals". www.accessdata.fda.gov. Retrieved 2015-05-19.