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Centocor withdraws imaging agent applications

Centocor withdraws imaging agent applications

Centocor is withdrawing Food and Drug Administration product license applications for two monoclonal antibody imaging agents: Myoscint, a cardiac agent, and Fibriscint, which targets blood clots.

The voluntary action follows the discovery of deficiencies in the applications, unearthed by an independent auditor engaged by Centocor. The company itself brought the deficiencies to the attention of the FDA.

"We had audits done of the applications and, basically, they found some deficiencies that we need to remedy before we refile," said Richard M. Koenig, spokesperson for the Malvern, PA, biotechnology company.

Problems with Myoscint's PLA may be remedied through a reanalysis of the existing data, after which the company plans to submit a revised license application, Koenig said.

Deficiencies found in the license application for the blood clot imaging agent, however, will not be so easily fixed.

"In the case of Fibriscint, we would have to do additional clinical work," Koenig said.

The decision to withdraw license applications for these two agents stems from action taken almost exactly a year ago, when Centocor contracted with King & Spalding, an Atlanta law firm with expertise in FDA matters, to independently audit all the company's license applications. The intent then was to identify any deficiencies or discrepancies that may have resulted from past work.

King & Spalding's assistance was enlisted after Centocor ran 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 aftermath of that, the FDA wanted us to do audits and we brought in an independent firm to do it."

Myoscint was the first monoclonal antibody imaging agent approved for market in Europe, although Cytogen's OncoScint cancer agent late last year became the first and only monoclonal imaging agent approved by the FDA (SCAN 1/27/93). Centocor intends to sell Myoscint in the U.S. through McNeil Pharmaceutical (SCAN 7/19/89).

Disclosures

 
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