Contract Manufacturer Deficiencies Stall ADMA Biologics Candidate

The FDA has rejected ADMA Biologics candidate for treatment of primary humoral immunodeficiency disease due to manufacturing deficiencies.

In a complete response letter declining the company’s BLA submission for RI-002, the agency pointed to problems with three contract manufacturers hired by ADMA.

ADMA said that the company hired to produce the drug failed an inspection, deficiencies were reported with another contract manufacturer hired to handle fill and finish and a third contractor that tested the products was cited for compliance issues.

FDA asked ADMA to provide proof that the three contractors have taken corrective action, and ADMA said it is monitoring the companies in an effort to resolve the issue.

The CRL did not cite any concerns with the clinical safety and efficacy data for RI-002, nor has the FDA requested any additional studies prior to approval.

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