ROCKVILLE, Md. -- Clear improvements in mortality for oneform of gram-negative infection led a Food and DrugAdministration advisory committee on Wednesday torecommend approval of Centocor's Centoxin product.
The Vaccines and Related Biological Products advisorycommittee recommended approval of Centoxin for patientswith gram-negative bacteremia who may also suffer fromseptic shock or endotoxemia. Several hours later, members ofthe same committee expressed reservations about rival XomaCorp.'s E5 antibody for treatment of gram-negative sepsis.
"Centocor's product came out looking better, there is noquestion about it," Richard Johnson, acting chairman of thecommittee, told BioWorld. "All of the panel members camedown with a favorable interpretation of what we werepresented with."
While the FDA may ask Xoma to perform more studies,"Centocor may not have to do anything -- that's why I thinkthey may be a little bit further along," Johnson said.
Stock of Malvern, Pa.-based Centocor (NASDAQ:CNTO) climbed$3 Wednesday, closing at $40.50.
Data from clinical trials of Centoxin showed a 30 percentreduction in mortality for patients with gram-negativebacteremia and a 39 percent reduction in mortality for gram-negative bacteremics with septic shock. But it showed nostatistically significant reductions in mortality or morbidityfor patients with gram-negative infections or sepsis withoutgram-negative bacteremia, said Dr. Craig Smith, Centocor'svice president of clinical research.
"We think gram-negative infections cause 60 percent to 70percent of sepsis," said Centocor spokesman Richard Koenig."Gram-negative bacteremia is an infection of the bloodstreamthat is a narrower indication than sepsis. We estimate it's 30percent to 40 percent of all sepsis cases. We had our bestresults with gram-negative bacteremics."
Committee members were unable to decide whether Centoxinshould be limited to patients with proven gram-negativeinfections or whether it should be presumptively administeredbefore a patient's condition worsens and the infection can beconfirmed.
-- Karen Bernstein contributed to this report.
-- Kris Herbst BioWorld Washington Bureau
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