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Posted on Jan 10, 2019, 8 p.m.
The FDA has approved antihemophilic factor recombinant PEGylated-auci for routine prophylactic treatment of hemophilia A in previously treated adults, children, and adolescents aged 12+; Jivi is also indicated for on demand treatment and perioperative management of bleeding in the same patient population.
Site specific PEGylation has a half life of 17.9 hours which delivers sustained levels in the blood, Jivi will replace the reduced or missing factor VIII in hemophilia patients; initial recommendation for prophylactic regimen is twice weekly; it can be administered every 5 days and be adjusted to less or more frequent dosing based on bleeding episodes of the individual.
Jivi trials included adults, children, and adolescents aged 12+ with severe hemophilia and demonstrated the ability to protect against bleeding episodes for a median of 1.9 years according to the company; and it was well tolerated in the majority of patients in the clinical trials with the most adverse reaction in previously treated patients being cough, headache, fever, and nausea.
Jivi has been submitted by Bayer for marketing authorization applications for the treatment of hemophilia A in Japan and in the European Union.
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https://www.medscape.com/viewarticle/901431
https://www.fda.gov/downloads/BiologicsBloodVaccines/UCM618985.pdf
