WASHINGTON (dpa-AFX) - ViroPharma Inc. (VPHM) announced that Health Canada has granted the company priority review status for its New Drug Submission, or NDS, for Cinryze.
The company noted that priority review allows for an expedited review of critical new drugs faster than a standard review. ViroPharma added that it has 60 days from the time of issuance of this acceptance letter to submit its full submission to Health Canada. Once submitted, review by Health Canada is expected to be completed in the second half of 2012.
Priority review for Cinryze was granted for three requested indications - treatment of angioedema attacks in adults, adolescents and children six years of age and above with hereditary angioedema, or HAE; pre-procedure prevention of angioedema attacks in adults, adolescents and children six years of age and above with HAE; and routine prevention of angioedema attacks in adults, adolescents and children six years of age and above with HAE.
Daniel Soland, ViroPharma's chief operating officer, said, 'We will submit the NDS to Health Canada before the end of this quarter, and look forward to a Canadian regulatory decision later this year.'
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