Regulatory Affairs

Shire secures FDA approval for technology transfer of Cinryze manufacturing process

Published 25 January 2018

Shire said that the US Food and Drug Administration has approved the technology transfer of Cinryze (C1 esterase inhibitor [human]) drug product manufacturing process to its Vienna, Austria manufacturing site.

CINRYZE is an injectable prescription medicine that is used to help prevent swelling and/or painful attacks in teenagers and adults with Hereditary Angioedema (HAE), a rare genetic disease.

Shire technical operations head Matt Walker said: "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.”

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.



Source: Company Press Release