Shire Wins Approval for Rare-Disease Drug Developed At Boston-Based Unit

8/25/11Follow @arleneweintraub

[Updated 8/25/11 12 p.m. See below.] Today the FDA approved icatibant (Firazyr), a drug made by Shire (NASDAQ: SHPGY) to treat a rare disease called hereditary angioedema. The drug, which Shire picked up in its 2008 acquisition of Germany-based Jerini, was developed for the U.S. market by Shire’s Human Genetic Therapies unit in Lexington, MA.

Hereditary angioedema is an inflammatory disease that affects about 8,000 people in the U.S.. Icatibant is approved to treat the disease’s major symptom: acute attacks of painful swelling, which can occur in various areas of the body, such as the face, hands, and feet.

Shire developed the drug as an injection just under the skin that patients can do themselves—a clear differentiation from other products on the market, which have to be dosed in hospitals or doctors offices. In June, an advisory committee to the FDA recommended that the agency approve the drug, and 11 out of the 13 members of the group voted in favor of self-administration. Today’s approval includes labeling that allows patients to inject themselves with the drug and includes counseling on how to do so.

That ability for patients to dose themselves should be a major marketing advantage, says Hugh Cole, global franchise leader at Shire Human Genetic Therapies. The drug inhibits a hormone called bradykinin, which is responsible for inflammatory symptoms such as pain and redness. There are competitors on the market that target other … Next Page »

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