The Conversation (0)
Shire Announces FDA Acceptance of sBLA for CINRYZE
Feb. 15, 2018 09:12AM PST
Pharmaceutical InvestingShire (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: …
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]
