ViroPharma Incorporated (VPHM)

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8:09AM ViroPharma: Analysis of pivotal study data showed routine prevention of Hereditary Angioedema (HAE) attacks with Cinryze (C1 esterase inhibitor [human]) resulted in improved health-related quality of life outcomes compared to acute therapy with C1 inhibitor while on placebo (VPHM) 49.42 : Co announced results of a new quality of life data analysis from the randomized, placebo-controlled pivotal prophylaxis study of Cinryze (C1 esterase inhibitor [human]), the first and only C1 esterase inhibitor therapy approved for routine prevention of angioedema attacks in patients with HAE.

The release of these data marks the first prospective evaluation of the impact of routine preventative treatment on the quality of life of patients with HAE. Quality of life data were specified in the protocol to be collected at the pre-treatment baseline and at the end of each of the two treatment periods but is not included in the prescribing information for Cinryze.

While the burden of HAE and the impact on patients' health-related quality of life (HRQoL) has been previously described, the effect of routine prophylaxis on quality of life has not been evaluated. The objective of this analysis was to evaluate the HRQoL of patients with HAE while they were receiving Cinryze either as routine prophylaxis or for the acute treatment of individual attacks in the absence of prophylaxis during a randomized, placebo-controlled, crossover study. HRQoL was measured by the Short Form-36 V 1.0 (SF-36) questionnaire, the standard patient-reported survey for patient health and quality of life. Cinryze is not approved by the FDA to treat HAE attacks.