FDA Approves Shire Manufacturing Move

The U.S. Food and Drug Administration has granted approval for the technology transfer of Shire’s 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).

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. It 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.

"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.