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Shire gets FDA approval for technology transfer of Cinryze drug
Shire has received approval from the US Food and Drug Administration for the technology transfer of its Cinryze drug product manufacturing process to its site in Vienna, Austria.
The biotechnology company will begin commercial manufacturing of Cinryze - an injectable medicine used to help prevent swelling and/or painful attacks in teenagers and adults with hereditary angioedema (HAE) - in the first quarter of this year.
Matt Walker, head of technical operations, 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."
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 and according to Shire, Cinryze is one of the leading therapies approved for its treatment in adolescent and adult patients. The medicine can help reduce how often attacks occur, how severe they are, and how long they last.
HAE can cause swelling attacks in any part of the body, but the most common locations include the abdomen, face, feet, genitals, hands and throat.
At 1300 GMT, the shares were down 0.8% to 3,482p.