Ramsey, New Jersey-based ADMA Biologics believes it has its ducks in order to move forward with its specialized plasma products to treat genetic disorders that were sidelined by manufacturing issues in 2016.
The biotech Wednesday reported that its Boca Raton, Florida, plant, which was hit with a warning letter in 2014, has been updated to Voluntary Action Indicated status by the FDA. ADMA has been upgrading the plant since acquiring it last year from its CDMO, Biotest Pharmaceuticals, in a deal in which the German company got half of ADMA’s stock.
The plant’s status change will allow for a third-quarter resubmission of its BLA for RI-002, a plasma-based biologic for the treatment of primary immune deficiency disease that was sidelined by a 2016 complete response letter tied the plant’s deficiencies.
“We are pleased that the FDA has acknowledged the improved current good manufacturing practice ('cGMP') conditions at our manufacturing facility and updated its database accordingly,” ADMA CEO Adam Grossman said in a statement.
In July, it reported the FDA had accepted its Prior Approval Supplement (PAS) to its biologics application for Bivigam, an intravenous immune globulin, that was pulled from the market in December 2016 because of the ongoing manufacturing issues. It has been granted a PDUFA target date of Oct. 25.
ADMA said the PAS submission specifically addressed production issues that had been laid out in the warning letter and a follow-up inspection in 2016. That includes data on product stability, process validation and specific production step-processing times, “as well as supporting data detailing the root cause of the filter clogging experienced by Biotest.”
“Since the acquisition of the Biotest Therapy Business Unit, ('BTBU') assets in June 2017, ADMA has been working diligently to address open quality, compliance and production issues which have affected the facility since 2014,” Grossman said in a statement.
The biotech has successfully manufactured three conformance lots of Bivigam which it intends to use to commercialize the product, assuming the FDA approves it in October. It anticipates a first-quarter 2019 relaunch.