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
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).