Baxalta Inc (NYSE:BXLT) has decided to submit the Market Authorization Application for ADYNOVI – a world class treatment for Hemophilia A Patients, to European Medicines Agency. There are many pediatric, adult and adolescent patients suffering from hemophilia A in different parts of the world. The new ADYNOVI can be used on such patients during the surgery to get desired results without any hassle.
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ADYNOVI, currently licensed in the United States of America under the name ADYNOVATE, is been reviewed carefully by the governments of Canada, Japan, and Switzerland. It’s the only rFVIII treatment developed for hemophilia A patients on the basis of demonstrated efficiency of ADVATE.
The senior management team of Baxalta Inc is delighted to announce the progress ADYNOVI has made lately. According to Brian Goff, President & EVP, Baxalta, results with regard to ADYNOVI are superb. Baxalta is committed to delivering it in different parts of the world to ensure that hemophilia A patients can be treated in the best way possible. Going forward, Baxalta will continue to build its portfolio of direct factor replacement treatments in order to serve all the hemophilia patients consistently.
To make sure that ADYNOVI works well on the target patient group, Baxalta had conducted separate studies on patients belonging to two age groups: those who are between 12-65-year-old and those who are younger than 12 years. Based on the positive results, it approached European Medical Agency and other authorities to get their approval.
Hemophilia A patients often face unexpected bleeding and need a constant infusion of treatment regimens under the monitoring of their healthcare advisor. It’s one of the most critical diseases across the globe. Baxalta hopes to deliver ADYNOVI in all parts of the world so that more and more patients can live a happy and peaceful lives.
Baxalta will target other countries once it receives approval in the nations mentioned above, details of which will be announced at a later date.