Shire receives FDA approval for tech transfer of Cinryze

Commercial manufacturing of Cinryze drug product in Vienna to begin in the first quarter of 2018.

“With the FDA’s approval of the tech transfer, we are pleased to strengthen our supply reliability for adult and adolescent HAE patients who count on Cinryze to help prevent attacks,” said Matt Walker, Head of Technical Operations.

Shire will begin commercial manufacturing of Cinryze drug product in Vienna in the first quarter of 2018. Cinryze will also continue to be produced by a third-party supplier, providing an additional supply source to meet patient demand.

Hereditary angioedema (HAE) is a rare genetic disorder that is thought to affect between 1 in 10,000 and 1 in 50,000 people in the world. HAE can cause attacks of swelling in any part of the body, but the most common locations include the abdomen, face, feet, genitals, hands and throat. HAE attacks affecting the throat are potentially life-threatening because patients are at risk of suffocation. The swelling in an HAE attack is sometimes painful and can happen without warning or an obvious trigger, lasting for days if untreated.

Cinryze (C1 esterase inhibitor [human]) is one of the leading therapies approved for the treatment of HAE in adolescent and adult patients. Cinryze can help reduce how often attacks occur, how severe they are, and how long they last. Shire’s OnePath program offers patients help with their access to the therapy and product support needs.