ViroPharma's NDS for Cinryze receives Health Canada's Priority Review status

Jan 13 2012

ViroPharma Incorporated (NASDAQ: VPHM) today announced that Health Canada has granted the company Priority Review status for its New Drug Submission (NDS) for Cinryze^™ (C1 inhibitor [human]).  Priority Review allows for an expedited review of critical new drugs faster than a standard review. ViroPharma 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 allows for an expedited review of a NDS for a serious, life-threatening or severely debilitating disease, or condition for which there is substantial evidence of clinical effectiveness that the drug provides effective treatment or prevention of a disease or condition for which no drug is presently marketed in Canada.  Priority Review status is not a decision by Health Canada on the drug's approvability; the safety and efficacy are still under investigation and market authorization has not yet been obtained in Canada. 

Priority Review for Cinryze was granted for all three requested indications: treatment of angioedema attacks in adults, adolescents and children six years of age and above with hereditary angioedema (HAE); pre-procedure prevention of angioedema attacks in adults, adolescents and children six years of age and above with HAE; and routine prevention (prophylaxis) of angioedema attacks in adults, adolescents and children six years of age and above with HAE.  There are currently no approved therapies for prevention of HAE attacks in Canada. 

HAE is a rare, debilitating and potentially life-threatening genetic disorder estimated to affect up to 3400 people across Canada.  HAE is a variable disease, and patients can experience unpredictable, recurrent and disabling attacks of swelling that can affect the upper airway, abdomen, face, extremities and urogenital tract due to a deficiency of C1 inhibitor, a human plasma protein that prevents swelling.

"The receipt of priority review status from Health Canada marks another important milestone in our efforts to make Cinryze available around the globe to people living with HAE through prevention and treatment of their attacks," said Daniel Soland, ViroPharma's chief operating officer.  "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."