Centocor is withdrawing Food and Drug Administration product licenseapplications for two monoclonal antibody imaging agents: Myoscint,a cardiac agent, and Fibriscint, which targets blood clots. The voluntary action follows the discovery of
Centocor is withdrawing Food and Drug Administration product licenseapplications for two monoclonal antibody imaging agents: Myoscint,a cardiac agent, and Fibriscint, which targets blood clots.
The voluntary action follows the discovery of deficienciesin the applications, unearthed by an independent auditor engagedby Centocor. The company itself brought the deficiencies to theattention of the FDA.
"We had audits done of the applications and, basically,they found some deficiencies that we need to remedy before werefile," said Richard M. Koenig, spokesperson for the Malvern,PA, biotechnology company.
Problems with Myoscint's PLA may be remedied through a reanalysisof the existing data, after which the company plans to submita revised license application, Koenig said.
Deficiencies found in the license application for the bloodclot imaging agent, however, will not be so easily fixed.
"In the case of Fibriscint, we would have to do additionalclinical work," Koenig said.
The decision to withdraw license applications for these twoagents stems from action taken almost exactly a year ago, whenCentocor contracted with King & Spalding, an Atlanta law firmwith expertise in FDA matters, to independently audit all thecompany's license applications. The intent then was to identifyany deficiencies or discrepancies that may have resulted frompast work.
King & Spalding's assistance was enlisted after Centocorran into problems with a monoclonal antibody called HA-1A/Centoxin,intended for therapeutic application.
"There was some controversy over previous work done with(this) therapeutic agent," Koenig said. "In the aftermathof that, the FDA wanted us to do audits and we brought in an independentfirm to do it."
Myoscint was the first monoclonal antibody imaging agent approvedfor market in Europe, although Cytogen's OncoScint cancer agentlate last year became the first and only monoclonal imaging agentapproved by the FDA (SCAN 1/27/93). Centocor intends to sell Myoscintin the U.S. through McNeil Pharmaceutical (SCAN 7/19/89).