The company's lead product, ecallantide, has been approved under the brand name KALBITOR([R])in the United States for the treatment of acute attacks of hereditary angioedema
(HAE) in patients 16 years of age and older.
In June 2010, Dyax announced a strategic partnership with Sigma-Tau to develop and commercialize subcutaneous DX-88 for the treatment of hereditary angioedema
(HAE) and other therapeutic indications throughout Europe, North Africa, Middle East and Russia.
Priority Review for Cinryze was granted for all three requested indications: treatment of angioedema attacks in adults, adolescents and children six years of age and above with hereditary angioedema
(HAE); pre-procedure prevention of angioedema attacks in adults, adolescents and children six years of age and above with HAE; and routine prevention (prophylaxis) of angioedema attacks in adults, adolescents and children six years of age and above with HAE.
Ecallantide for the treatment of acute attacks of hereditary angioedema
This open-label multiple-dose study will be conducted in subjects with hereditary angioedema
who previously participated in the ViroPharma Phase 2 trial evaluating subcutaneous Cinryze when given alone.
EDEMA4[R]: A phase 3, double-blind study of subcutaneous ecallantide for acute attacks of hereditary angioedema
(HAE) is a rare genetic disease characterized by acute episodes of severe, often painful swelling affecting the extremities, the gastrointestinal tract, the genitalia, and in the larynx.
Pre-procedure Administration of C1 Esterase Inhibitor (Human) (C1 INH-nf) for the Prevention of Hereditary Angioedema
(HAE) Attacks after Medical, Dental, or Surgical Procedures
Health-Related Quality of Life Burden Associated with Androgen Therapies for Hereditary Angioedema
In a poster entitled, 'Pre-procedural Administration of Nanofiltered C1 Esterase Inhibitor (Human) (Cinryze) for the Prevention of Hereditary Angioedema
(HAE) Attacks after Medical, Dental, or Surgical Procedures,' Dr.
Patients with hereditary angioedema
live with the constant threat of severe and potentially life-threatening angioedema attacks," said Bruce Zuraw, MD, Program Director of the Allergy and Immunology Fellowship Program at the University of California at San Diego and the study's primary investigator.
March 18, 2011 /PRNewswire/ -- ViroPharma Incorporated (Nasdaq: VPHM) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion at its plenary meeting in March 2011 recommending approval of a Centralized Marketing Authorization for Cinryze (C1 inhibitor [human]) in adults and adolescents with hereditary angioedema
(HAE) for routine prevention, pre-procedure prevention and acute treatment of angioedema attacks.