The US Food and Drug Administration (FDA) has announced the approval of a pooled human plasma blood product for use in patients with deficient clotting proteins in their bloodstream, bringing to the US for the first time a product that has been used "extensively" in foreign markets since 2006.
The product, Octaplas, is a sterile, frozen solution of pooled human plasma derived from multiple screened donors. That plasma is then treated with a "solvent detergent process" that kills viruses capable of causing "serious virus transmission," FDA explained.
"For patients suffering with clotting disorders, this product provides a viable alternative to single-donor fresh-frozen plasma and provides a reduced risk of certain viral transmissions," said Karen Midthun, director of the FDA's Center for Biologics Evaluation and Research, in a statement.
Regulators further noted that the product has been available in foreign markets since 2006, and a previous generation since 1992.
No explanation was given for the six-year delay in availability to US patients. In a statement provided to Regulatory Focus, FDA spokeswoman Rita Chappelle indicated the delay might be due to the company, and not on the part of FDA.
"The timing of approvals is based on when the firm submits the application and any additional information that may be required. In the Case of Octaplas, FDA met all of the PDUFA review goals," Chappelle said.
Octapharma submitted its biologics licensing application (BLA) to FDA on 28 February 2012, just nine months after receiving a warning letter from FDA over alleged manufacturing deficiencies found at one of its flagship manufacturing facilities. The company did not provide any clarification regarding the delay in US market entry in its press statement announcing the submission.
An FDA document produced in 2012 in advance of the product's advisory committee meeting indicated that the drug had actually been available in the EU since 2009-not 2006 as explained in its press release. A request to FDA to explain the discrepancy was not returned.
The product was deemed to be effective by FDA's Blood Products Advisory Committee, and gained full FDA approval on 17 January 2013.