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CORRECTED - CORRECTED-UPDATE 1-U.S. advisers back Shire drug
June 23, 2011 / 8:15 PM / in 6 years

CORRECTED - CORRECTED-UPDATE 1-U.S. advisers back Shire drug

(Corrects to remove reference to ViroPharma drug requiring injection by a doctor)

* Shire drug safe, effective for angioedema - FDA panel

* Panel also says drug, Firazyr, safe for self-injection

* FDA to decide on drug approval by Aug. 25

SILVER SPRING, Md., June 23 (Reuters) - A U.S. advisory panel on Thursday said Shire Plc’s (SHP.L) drug was safe and effective in treating a rare genetic disease.

A committee of Food and Drug Administration advisers voted 12-1 for recommending approval of the drug, to be marketed as Firazyr, for treating hereditary angioedema (HAE).

Advisers also said the drug was appropriate for self-injection, giving it a boost versus competitor drugs from Dyax DYAX.O and CSL Behring, which must be injected by physicians. ViroPharma Inc VPHM.O also sells a treatment for this condition.

HAE can cause sudden attacks of swelling in areas such as hands, arms, feet, face or breathing passages, and affects less than 30,000 people in the United States, Shire said. The drug was given orphan status by the FDA.

The FDA usually approves medicines that win advisory panel backing. It is expected to rule on the drug by Aug. 25. (Reporting by Anna Yukhananov; editing by Carol Bishopric)

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