ViroPharma issued guidance from FDA to resume clinical studies

theflyonthewall.com

ViroPharma (VPHM) and Halozyme (HALO) announced that the FDA has provided guidance enabling ViroPharma to resume clinical studies of the subcutaneous administration of Cinryze in combination with rHuPH20. The FDA informed ViroPharma that based upon their ongoing assessment, the FDA believes the potential safety signals regarding antibodies to rHuPH20 that were detected in the clinical development program of another company's product are limited to that specific program. According to Halozyme, the detected antibodies were non-neutralizing and not associated with any clinical adverse events. The FDA has advised ViroPharma to amend the study protocol, allowing for increased laboratory sampling to monitor rHuPH20 antibody levels, and keep the Agency informed of elevated antibody levels during the treatment phase of the study.

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