(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 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
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)