GAITHERSBURG, Md. _ What looked like a cakewalk forGenzyme Corp. turned into somewhat of a disappointment Mondaywhen an FDA advisory panel recommended Seprafilm be marketedonly for certain surgical uses and that the manufacturer conduct afollow-up study that may prove impossible to complete.
The FDA's General and Plastic Surgery Devices panel voted 5-1 torecommend conditional approval of Seprafilm provided the labelingstates it is indicated to be used only for those surgical situationsstudied in the premarket approval application, and Genzyme shouldperform a post-marketing approval study for possible adverse events.
Panel members were concerned Seprafilm might cause abscesses andthat it might migrate from the site where the surgeon placed it.
If the FDA follows the panel's recommendations regarding thelabeling, Seprafilm would be restricted to abdominal incisions.Because the panel members were split on which organs it should beapplied to in order to reduce the incidence of adhesions, the FDA willhave to sort out this issue through discussions with Genzyme.
Genzyme's stock (NASDAQ:GENZ) fell $6.25 Monday to close at$57.25.
The feasibility of performing a clinical trial that subjected patients totwo surgical procedures was vehemently questioned by panel memberMary McGrath, chief of plastic and reconstructive surgery at GeorgeWashington University in Washington. McGrath, who voted againstthe restrictions on Seprafilm and supported wider use, remindedpanel members they should be "sensitive to the fact that it may not bepossible to perform a `second look' operation to determine theclinical effectiveness of Seprafilm to reduce adhesions."
Seprafilm is a bioresorbable membrane that prevents fibrin,unleashed as the result of surgical insult, from building thescaffolding needed for adhesions. The film liquefies into a gel and iscompletely excreted by the body in three to five days.
Seprafilm has the ability to reduce some of the estimated $1.1 billionin hospital costs and $250 million in surgeon fees associated withsurgeries to remove adhesions, said Titus Duncan, an Atlanta surgeonwho served as the panel member responsible for reviewingGenzyme's premarket approval application.
Genzyme, of Cambridge, Mass., initially sought a widerinterpretation of Seprafilm's labeling to permit its use anywhere inthe abdominal cavity, but subsequently added language specifying itshould be used only for those conditions studied. In a clinical trial ofgynecological surgery patients, Seprafilm was found to be effective inreducing the severity and extent of adhesions on the anterior of theuterus.
David Berkowitz, the FDA's lead reviewer, noted the "vast majorityof surgical patients end up with adhesions that are associated withserious morbidities. Clearly a product that can influence these rateswould one of major importance to physicians and patients."
Duncan pointed out that Seprafilm is superior to currentpharmaceutical treatment such as NSAIDs and calcium channelblockers that seek to reduce inflammation at the site of the surgicalincision.
However, Genzyme's claim that Seprafilm is effective generallythroughout the abdominal cavity "was not supported by the data,"Duncan told the panel. "The manufacturers did not study small bowelobstructions but it claims to prevent them."
Concerned that the device might migrate through the abdominalcavity, Duncan urged the panel to recommend a post-marketingsurveillance study to monitor why the device works in some patientsand has no effect in others. n
-- Michele L. Robinson Washington Editor
(c) 1997 American Health Consultants. All rights reserved.