ViroPharma Submits Supplemental Biologics License Application For Cinryze(TM) To Treat Acute Attacks Of Hereditary Angioedema
Dec 4th 2008Drug InformationClinical Trials
ViroPharma Incorporated (Nasdaq: VPHM) announced that the company submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for Cinryze(TM) C1 Inhibitor (human) as a treatment for acute attacks of hereditary angioedema (HAE). The sBLA is based on a re-analysis and resubmission of data from a pivotal Phase 3 acute treatment study of Cinryze and interim data from an ongoing open label acute study of the drug.
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