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Title: FDA Approves C1 Inhibitor Protein for the Prevention of Hereditary Angioedema Attacks
URL: http://www.pslgroup.com/dg/22E8A6.htm
Doctor's Guide
October 10, 2008

ROCKVILLE, Md -- October 10, 2008 -- The US Food and Drug Administration (FDA) has approved a C1 inhibitor human protein [Cinryze] for the prevention of attacks in patients with hereditary angioedema (HAE).

"[The inhibitor] should greatly enhance treatment options for those with hereditary angioedema and potentially save lives," said Jesse Goodman, MD, FDA's Center for Biologics Evaluation and Research, Rockville, Maryland.

In clinical trials, the product was effective in preventing or decreasing the frequency of attacks in most but not all patients with HAE. Adverse reactions reported in the study were considered mild or moderate in severity.

SOURCE: US Food and Drug Administration

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