http://www.bioworld.com/content/other-news-note-5881
Monday, August 3, 2015
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Adma Biologics Inc., of Ramsey, N.J., said it submitted a biologics license application to the FDA seeking approval of RI-002, a specialty plasma-derived, polyclonal, intravenous immune globulin derived from human plasma containing naturally occurring polyclonal antibodies (e.g., Streptococcus pneumoniae, H. influenza type B, cytomegalovirus, measles, tetanus, etc.) as well as standardized, high levels of antibodies to respiratory syncytial virus. The drug demonstrated positive results in a phase III study in patients with primary immunodeficiency (PI), meeting its primary endpoint of no serious bacterial infections (SBI). Those results, included in the submission, more than meet the requirement specified by the FDA guidance of less than or equal to one SBI per patient-year, the company said. PI is a class of inherited genetic disorders that causes an individual to have a deficient or absent immune system due to either a lack of necessary antibodies or a failure of these antibodies to function properly. It affects roughly 250,000 people in the U.S.