(Adds background, details on Bivigam)
Dec 19 (Reuters) - The U.S. Food and Drug Administration (FDA)on Wednesday declined to approve ADMA Biologics Inc’s application to re-launch its immune deficiency treatment Bivigam, the company said.
The FDA decision comes more than two years after the drug’s previous owner suspended its production.
Bivigam is a treatment given through the veins for patients with primary humoral immunodeficiency, a condition that compromises the body’s ability to fight infections.
ADMA Biologics, which specializes in plasma-based products for treating infectious diseases, acquired Bivigam in 2017 from privately-held Biotest Pharmaceuticals, along with its plasma processing facility in Boca Raton, Florida.
Biotest sold the facility after receiving a warning letter from the FDA, citing deviations from formal regulatory guidelines.
ADMA Biologics’ RI-002, a blood-derived treatment for primary immune deficiency diseases - a class of inherited genetic disorders, is slated for regulatory review in April, 2019.
If the company gets approval, the treatment is expected to add $260 million in sales by 2032, according to an estimate by brokerage Oppenheimer. (Reporting by Manogna Maddipatla and Aakash Jagadeesh Babu in Bengaluru; Editing by James Emmanuel)