FDA Grants Approval to Shire for Technology Transfer of CINRYZE® Drug Product Manufacturing Process to Vienna

Shire (NASDAQ:SHPG) the global biotechnology leader in rare diseases, announced today that the U.S. Food and Drug Administration has granted approval for the technology transfer of CINRYZE^® 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, a rare genetic disease.
As quoted in the press release:

“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.

Click here to read the full press release.