Thrombotargets Corp announced today that it has submitted its Orphan Drug Application of TT-103MH to the FDA for bleeding treatment in von Willebrand patients.
Thrombotargets Corporation announced today that it has submitted its Orphan Drug Application of its Human Recombinant protein known as
TT-103MH to the United States Food and Drug Administration (FDA) for bleeding treatment in von Willebrand patients “ We are extremely proud and remain very optimistic that the FDA will look favorably on this designation, said Dr. Pedreño Thrombotargets President and CEO, “We remain very optimistic given the early Laboratory results, that demonstrate that
TT-103MH is a viable and a very efficacious alternative to current replacement therapy in hereditary coagulation disorders as von Willebrand diseases and considering previous TT-103MH Orphan Drug Designation for the treatment of Hemophiliacs ” said Dr. Pedreño president and CEO.
The FDA grants orphan drug status for drug candidates that are intended to treat rare life-threatening diseases that, at the time of application, affect no more than 200,000 patients in the United States. The drug must have the ability to provide significant patient benefit over currently available treatment or fill an unmet medical need. Orphan drug designation entitles Thrombotargets corp. to seven years of market exclusivity in the United States upon FDA approval, provided that Thrombotargets Corp. continues to meet certain conditions established by the FDA.
About Thrombotargets Group
Thrombotargets
(www.thrombotargets.com) is a privately held group of Biotech companies focused in the discovery and development of innovative drugs in Haemostasis, Thrombosis and Atherosclerosis. The company has a number of potential new drugs in development internally and its proprietary targets and innovative uHTS platforms are used for internal drug discovery programs, as well as for out-licensing and partnering of new research projects.
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