ADMA Biologics Inc, an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing, and developing specialty plasma-derived biologics, announced the US Food and Drug Administration (US FDA) has approved the company’s supplemental Biologics License Application submitted under section 351(a) of the Public Health Service Act for Bivigam.
The US FDA approval represents the final study report for the Pediatric assessment as required in the post marketing commitment. Additionally, the approval provides for a revision of Bivigam’s prescribing information to expand the primary humoral immunodeficiency (PI) indication to pediatric patients 2 years of age and older.
"We are pleased to announce that Bivigam has received US FDA approval for treating PI in patients aged 2 years and older. Previously, the indication for BIVIGAM was restricted to PI patients aged 12 years and older,” said Adam Grossman, president and CEO of ADMA. “This expanded label for Bivigam allows ADMA to actively address the treatment needs of younger PI patients earlier in their treatment journey. In the periods ahead, we look forward to offering Bivigam as a US FDA-approved treatment option for these pediatric PI patients,” said Grossman.
“We extend our gratitude to the collaborative efforts of the PI disease community, physicians, and the invaluable contribution of the children and families who played a pivotal role in advancing this clinical program,” said Kaitlin Kestenberg, senior vice president, compliance & project operations. “Enrolling and successfully completing these challenging trials is no small feat, and this approval is a testament to the commendable clinical execution and the dedication of the ADMA team.”
ADMA Biologics currently manufactures and markets three United States Food and Drug Administration (FDA)-approved plasma-derived biologics for the treatment of immune deficiencies and the prevention of certain infectious diseases: Bivigam (immune globulin intravenous, human) for the treatment of primary humoral immunodeficiency (PI); Asceniv (immune globulin intravenous, human – slra 10% liquid) for the treatment of PI; and NABI-HB (hepatitis B immune globulin, human) to provide enhanced immunity against the hepatitis B virus. ADMA manufactures its immune globulin products at its FDA-licensed plasma fractionation and purification facility located in Boca Raton, Florida. Through its ADMA BioCenters subsidiary, ADMA also operates as a US FDA approved source plasma collector in the US, which provides its blood plasma for the manufacture of its products. ADMA’s mission is to manufacture, market and develop specialty plasma-derived, human immune globulins targeted to niche patient populations for the treatment and prevention of certain infectious diseases and management of immune compromised patient populations who suffer from an underlying immune deficiency, or who may be immune compromised for other medical reasons.
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