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12:00 AM
May 05, 2003
 |  BioCentury  |  Regulation

Serostim: Moving the goal posts

The CPMP's recommendation that EMEA reject marketing approval for Serono S.A.'s Serostim somatropin illustrates the problems companies can encounter when the U.S. and Europe have different definitions of diseases and clinical endpoints. Indeed, last week's negative opinion on the recombinant human growth hormone to treat AIDS-related wasting syndrome (cachexia) appears to be more of a policy issue than a fault in clinical trial design.
The committee's rejection was based on its belief that the benefit-to-risk ratio for Serostim was unfavorable and that a target population could not be identified because the patient population had heterogeneous body compositions and were on multiple drug regimens.
The CPMP also noted that it was unsure about the clinical relevance of the primary endpoints studied, which included the positive effect of Serostim on work output and lean body mass (LBM). Furthermore, the committee said the application lacked long-term controlled efficacy data,...

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