ADMA Pushes Documentation for New PIDD Biologics Through to Next Stage
August 22, 2015
ADMA Biologics, Inc., a late‐stage biopharmaceutical company that develops, manufactures and intends to commercialize specialty plasma‐based biologics for the primary immunodeficiency (PI) population and the treatment and prevention of certain infectious diseases, announced that it has submitted its Biologics License Application (BLA) to the United States Food and Drug Administration (FDA), seeking marketing authorization for their new product “RI‐002.”
What is RI-002? This product is a specialty plasma‐derived, polyclonal, intravenous immune globulin (IGIV) derived from human plasma containing naturally occurring polyclonal antibodies (e.g., Streptococcus pneumoniae, H. influenza type B, cytomegalovirus (CMV), measles, tetanus, etc.) as well as standardized, high levels of antibodies to respiratory syncytial virus (RSV). ADMA is pursuing an indication for the use of this specialty IGIV product for treatment of patients diagnosed with primary immune deficiency disease (PIDD).
RI‐002 demonstrated positive results in a Phase III study in patients with PI, meeting its primary endpoint of no serious bacterial infections (SBI). These results, included in the submission, more than meet the requirement specified by the FDA guidance of ≤ 1 SBI per patient‐year.
“The BLA submission for RI‐002 is a significant milestone for our growing company,” stated Adam Grossman, President and CEO of ADMA Biologics. “This submission, combined with our recent announcement of obtaining patent protection for RI‐002, places ADMA in a rare position as a company poised to transition from development to commercial stage. We believe that RI‐002, if approved by the FDA, has great potential to provide meaningful clinical improvement for patients living with PI, as well as offers clinicians a much needed option for their immune compromised patients. Under PDUFA V, the BLA filing fee is $2.3 million. The FDA reviewed ADMA’s small business waiver application and it was approved.”
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,affecting approximately 250,000 people in the United States. The FDA has a 60‐day review period to determine whether ADMA’s BLA submission for RI‐002 is complete and acceptable for filing.
About ADMA Biologics, Inc.
ADMA is a late‐stage biopharmaceutical company that develops, manufactures and intends to market specialty plasma‐based biologics for the treatment and prevention of PI and certain infectious diseases. ADMA’s mission is to develop and commercialize plasma‐derived, human immune globulins targeted to niche patient populations for the treatment and prevention of certain infectious diseases. The target patient populations include immune‐compromised individuals who suffer from an underlying immune deficiency disease, or who may be immune‐compromised for medical reasons. ADMA’s lead product candidate, RI‐002, for which a notice of allowance for a U.S. patent was granted pertaining to RI‐002 entitled “Compositions and Methods for the Treatment of Immunodeficiency,” has completed a Phase III clinical trial in patients with primary immune deficiency disease (PIDD) and has met the primary endpoint. A BLA for RI‐002 was submitted to the FDA on July 31, 2015. For more information, please visit the company’s website at www.admabiologics.com.
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