SAINT HELIER (dpa-AFX) - Shire plc (SHPG, SHP.L) said that it will present additional data on the clinical experience of ADYNOVATE [Antihemophilic Factor (Recombinant), PEGylated], an extended half-life recombinant Factor VIII (rFVIII) replacement for hemophilia A, during the International Congress of the World Federation of Hemophilia (WFH) in Orlando, Florida. Throughout the Congress, Shire will present more than a dozen scientific updates on the company's broad portfolio of treatments for bleeding disorders, including ADYNOVATE.
Hemophilia A is a challenging chronic disease; treatment regimens require regular infusions to reduce the risk of bleeding. Today, hemophilia A affects more than 400,000 people globally and WFH estimates 45 percent of hemophilia A patients in the United States are under the age of 18.
With ADYNOVATE, Shire has expanded its leading hemophilia portfolio with a wide variety of options, helping to further personalize hemophilia A care for pediatric patients. ADYNOVATE is the first extended half-life rFVIII treatment built on a proven protein, ADVATE [Antihemophilic Factor (Recombinant)]. Designed to extend the time FVIII circulates in the body, ADYNOVATE provides dosing flexibility to help achieve personalized treatment goals.
Data will be presented from a global, open-label Phase 3 study designed to assess the safety and efficacy of a twice-weekly prophylactic ADYNOVATE regimen to control bleeding in previously-treated children under the age of 12. ADYNOVATE met its primary endpoint in the study, as no patients developed inhibitory antibodies to ADYNOVATE. Nearly 40 percent (37.9 percent) of patients experienced no bleeding episodes and more than 70 percent (72.7 percent) of patients had no joint bleeds. Of the bleeding episodes that did occur, none were considered major. The study also assessed the median annualized bleeding rate (ABR), which was 2.0 [mean ABR 3.0 (2.2 - 4.2)]. These comprehensive results reinforce initial data reported from this study in December 2015.
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