Shire Announces FDA Acceptance of sBLA for CINRYZE

Shire (NASDAQ: SHPG), the global biotechnology leader in rare diseases, announced today that the U.S. Food and Drug Administration (FDA) accepted the CINRYZE^® (C1 esterase inhibitor [human]) supplemental Biologics License Application (sBLA) to expand the currently approved indication to include children aged 6 years and older with hereditary angioedema (HAE).

As quoted in the press release:

CINRYZE has been approved in the U.S. since October 2008 for routine prophylaxis against attacks in adolescents and adults living with HAE.^[1] HAE is a rare, genetic disorder that results in recurring attacks of edema (swelling) in various parts of the body, including the abdomen, face, feet, genitals, hands and throat.^{[2], [3], [4]} It is estimated to affect about 1 in 10,000 to 1 in 50,000 people worldwide.^[5]

Click here to read the full press release.