FDA Approves Expanded Use of ADMA Biologics’ Bivigam in PI

Rare Daily Staff

The U.S. Food and Drug Administration approved ADMA Biologics supplemental Biologics License Application for Bivigam, expanding the primary humoral immunodeficiency indication to pediatric patients 2 years of age and older.

Primary humoral immunodeficiencies (PI) are predominantly antibody deficiencies characterized by B cell-intrinsic abnormalities that classically result in decreased B cell numbers, impaired antibody production, or both. There are more than 400 different kinds of PI. With PI, part of your immune system, which is what protects you from infections and fights off diseases, is missing or doesn’t function properly. As a result, your body can’t protect you from germs as well as it should, so you are more likely to develop infections and be sick more often.

Because the defects are largely restricted to B cells, primary humoral immunodeficiencies are distinguished separately from other immunodeficiencies in which abnormal B cell activity plays only a partial role in the disease manifestation.

The FDA approval represents the final study report for the pediatric assessment as required in the post marketing commitment.

“We are pleased to announce that Bivigam has received 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.”

Photo: Adam Grossman, president and CEO of ADMA