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FDA gives ViroPharma's Cinryze priority review

2/4/2009

EXTON, Pa. The Food and Drug Administration has given priority review to a supplemental approval application from ViroPharma for the biologic drug Cinryze.

The FDA approved Cinryze (C1 inhibitor [human]) in October as a preventive drug against angioedema attacks in adolescent and adult patients with hereditary angioedema, a potentially life-threatening inflammatory disease that affects at least 4,600 Americans. ViroPharma submitted the supplemental application seeking approval for Cinryze as a treatment for acute HAE attacks following a phase 3 study.

The FDA gives priority review to drugs that address unmet medical needs and demonstrate improvements over existing therapies.

"The priority review designation marks a positive step in bringing another use of Cinryze closer to the patients who suffer acute attacks of hereditary angioedema," ViroPharma president and CEO Vincent Milano said in a statement. "We look forward to working with the FDA on approval so that we can help this additional group of patients."

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