Shire Receives Approval of FIRAZYR (icatibant injection) for the Treatment of Hereditary Angioedema (HAE) Attacks in Japan

Shire (LSE:SHP,NASDAQ:SHPG) the leading global biotechnology company focused on rare diseases, announced that the Ministry of Health, Labour and Welfare (MHLW) in Japan has granted manufacturing and marketing authorisation for FIRAZYR (icatibant injection), for the acute treatment of hereditary angioedema (HAE) attacks in adult patients with HAE.

As quoted in the press release:

HAE is a rare genetic disease characterised by recurrent attacks of localized oedema (swelling). The areas of the body most commonly affected are the extremities, skin, gastrointestinal tract and, less frequently, HAE can cause life-threatening attacks due to obstruction in the upper airways. Symptoms of HAE often present in childhood, and while attacks can occur at any age, early onset may predict a more severe disease course.

“As a long-term partner to the HAE community, we continually strive to bring treatments to those living with HAE around the world,” said Andreas Busch, Ph.D., Executive Vice President, Head of Research and Development at Shire. “HAE attacks can be unpredictable and debilitating and we are delighted that, subject to price listing, we will be able to provide the Japanese HAE community with the first subcutaneous on-demand therapy to treat acute HAE attacks.”

For most people, attacks of HAE are caused by a deficiency of a protein called C1-esterase-inhibitor (C1-INH), either there is not enough of it or it does not function properly. Without sufficient or functional C1-INH, plasma kallikrein in the body is not appropriately controlled. Overactive plasma kallikrein leads to excessive release of bradykinin which causes blood vessels to release fluid, leading to the swelling which characterises HAE. FIRAZYR works by blocking bradykinin from binding to certain receptors in the body, thereby treating the symptoms of acute attacks of HAE.

Click here to read the full press release.