Shire advances rival to Dyax drug
Boston Business Journal - by Julie M. Donnelly
Date: Monday, March 21, 2011, 10:47am EDT
.Shire plc (NASDAQ: SHPGY) has announced that the U.S. Food and Drug Administration will make an approval decision August 25 for its drug candidate to treat the rare disease hereditary angioedema (HAE). The drug target, if approved, would put UK-based Shire, whose rare disease unit is based in Lexington, Mass., in direct competition with Cambridge, Mass.-based Dyax Corp., whose drug for HAE was approved in Dec. 2009.
The Boston Business Journal reported on March 4 that Dyax could face competition within six months. Shire has more experience with the unique sales environment surrounding rare-disease patients. The company already has two drugs on the market to treat rare diseases, when it was called upon to speed up development of its alternative to Genzyme Corp.’s (Nasdaq: GENZ) Gaucher disease drug, following Genzyme’s Allston plant shutdown in the summer of 2009. Dyax’s drug for HAE, called Kalbitor, is its first on the market.
But Shire’s drug has previously faced setbacks with U.S. regulators. The drug was the prize asset of Jerini, a German company Shire bought in 2008, after the drug was approved in Europe. But the drug received a “not-approvable” letter from the U.S. Food and Drug Administration, forcing Shire to do an additional Phase III clinical trial. Shire reported positive results from the trial in December 2010 and re-submitted the drug candidate to the FDA earlier this month.
The company will ask the FDA to include a label allowing for the injection to be self-administered by the patient. This could make the drug a more convenient alternative to the Dyax drug, which must be administered in a health care setting such as an emergency room. Shire’s drug is currently approved outside in 37 countries and is marketed under the name Firazyr.
Shire said almost all subjects who were treated with Firazyr in clinical trials developed injection site reactions including skin irritation, swelling, pain, itchiness, erythema, and burning sensation. The company said caution should be used in treating patients with acute ischemic heart disease or unstable angina pectoris and in the weeks following a stroke.
HAE is a rare genetic disease characterized by swelling of various parts of the body and can be life-threatening in the case of attacks to the larynx.
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