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is also being investigated in a randomised Phase II clinical trial for prophylaxis of HAE as well as being evaluated for various additional follow-on indications.
Our approved product, KALBITOR, was an important first step to bringing a range of HAE medicines to patients.
HAE is caused by a deficiency of the C1 esterase inhibitor protein, which is present in blood and helps control inflammation (swelling) and parts of the immune system.
Costs for HAE drugs are increasing at the same time the number of people being treated is increasing, and a subset of people incurred substantial treatment costs," said Patrick Gleason, PharmD, director of health outcomes at Prime.
With today's FDA approval of FIRAZYR, Shire has initiated a Quick Start program and extended its OnePath Access Program to offer a wide range of product-related services and support to HAE patients.
This article aims to provide an overview of the pathologic features and clinical presentation of HAE, with a view toward improving the differential diagnosis and enhancing effective management.
After years of debate about whether angioedema is caused by activation of the complement or the contact systems, it is now generally agreed that bradykinin is probably the only mediator of angioedema attacks in HAE (9).
Opponents of Scots Wha Hae often say it's a dirge, while Flower of Scotland is more upbeat.
Moscicki, senior vice president and chief medical officer for Genzyme, said: "Patients suffering with HAE are desperate for a treatment, and our goal is to make one available to them as quickly as possible.
RUCONEST is also being investigated in a randomised Phase II clinical trial for prophylaxis of HAE, in a Phase II clinical trial for the treatment of HAE in young children (2-13 years of age) and evaluated for various additional follow-on indications.
KALBITOR Development HAE Program The approval of KALBITOR is based on the results of two placebo-controlled Phase 3 clinical studies, known as EDEMA3[R] and EDEMA4[R].
We believe the additional body of pediatric clinical data in children under 13 years of age are in line with the excellent data in adolescents (13-18 years of age) and adult HAE patients treated with RUCONEST[sup.