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Shire submits IND application to the US FDA

06 July 2017 13:20

Shire has announced that it has submitted an investigational new drug (IND) application to the US Food and Drug Administration (FDA) for SHP654, also designated as BAX 888.

This is an investigational factor VIII (FVIII) gene therapy for the treatment of hemophilia A which aims to protect hemophilia A patients against bleeds through the delivery of a long-term, constant level of factor expression.

"Shire is leveraging decades of scientific leadership in hemophilia to advance research in gene therapy for this community," said Paul Monahan, M.D., Senior Medical Director, Gene Therapy, Shire.

"Drawing from our rich heritage, Shire is well equipped to sustainably support the development of gene therapies that aim to advance current standards of care and minimize the burden of this disease. SHP654 uses a proprietary technology platform designed to produce sustained levels of factor similar to the natural mechanisms of the body. Our goal with gene therapy for hemophilia is to uphold the highest standards for safety and efficacy."

At 1:20pm: (LON:SHP) Shire PLC share price was +25p at 4358.5p

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