LONDON (Alliance News) - Pharmaceutical company Shire PLC on Friday said it has been granted manufacturing and marketing authorisation in Japan for its hereditary angioedema drug, Firazyr.
The Japanese Ministry of Health, Labour & Welfare has approved Firazyr to treat adult patients with the rare genetic disease, which occurs in between 1 in 10,000 and 1 in 50,000 people worldwide.
Hereditary angioedema causes swelling, most commonly in the extremities and the skin, but occasionally and most dangerously it can cause life-threatening obstruction of the upper airways.
Firazyr was approved in Japan on the basis of a phase three trial of eight adult patients, which showed that the drug was tolerated well by patients and caused demonstrable symptom relief during attacks of swelling within an average time frame of 1.8 hours.
"Hereditary angioedema attacks can be unpredictable and debilitating and we are delighted that, subject to price listing, we will be able to provide the Japanese hereditary angioedema community with the first subcutaneous on-demand therapy to treat acute hereditary angioedema attacks," said Shire Executive Vice President Andreas Busch.
Shares in Shire were up 0.4% at 4,526.00 pence on Friday.
