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CENTOCOR MUST PERFORM SECOND TRIAL OF CENTOXIN

Executive Summary

CENTOCOR MUST PERFORM SECOND TRIAL OF CENTOXIN before FDA will resume its review of the company's product license application for the monoclonal antibody product for septic shock. In an unusual public comment on the status of Centoxin, FDA said April 17 that it has "requested that Centocor submit data from an additional well-controlled trial before further consideration of the PLA for HA-1A for the treatment of gram negative sepsis." The FDA announcement follows on the heels of an April 15 company release revealing that FDA had deemed currently available data for Centoxin as "insufficient evidence of efficacy for approval at this time." FDA's Vaccines and Related Biological Products Advisory Committee had found the product safe and effective at a meeting last September ("The Pink Sheet" Sept. 9, 1991, p. 14). Centocor explained that FDA expressed concern that an analysis of "some interim efficacy data," which took place "before a revised analytical plan was finalized," may have influenced the results of the company's only large scale trial of HA-1A. Centocor submitted data on 616 patients for review by the advisory committee. "Centocor's claim of efficacy was based on an analysis of a subset of 200 study patients with sepsis ultimately found to have gram-negative bacterial infections in the bloodstream." The study endpoint in the original protocol was 14 days. "There was no statistically significant difference in survival between treated and placebo groups 14 days after treatment," according to the FDA statement. Prior to completion of the study, Centocor submitted a revised analytical plan adding a new primary endpoint, FDA said: survival over 28 days. During that period, 45 of 95 placebo-treated patients died, compared with 32 of 105 HA-1A treated patients, a difference of "marginal statistical significance" according to FDA but great enough to garner the committee's guarded recommendation. At the time of the advisory committee meeting, the agency was not aware of the interim analysis. "Subsequent to this meeting, FDA learned that certain Centocor staff were aware of the results of some interim analyses prior to the final submission to the agency of the revised analytical plan," FDA said. "Because of the potential for introduction of bias, results of analyses based upon this plan cannot be accepted." Centocor emphasized that company "personnel continue to work with the agency's staff to identify the most effective manner in which to develop" the required additional data." The company says it remains "hopeful that approval can be achieved later this year." Since receiving the committee's favorable recommendation, Centocor has been gearing up for approval of the product: the company expanded its U.S. Centoxin sales force by forty sales reps during the week of Dec. 30-Jan. 3, increasing the total to 200 ("The Pink Sheet" Jan. 13, T&G-5).

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