The European Medicines Agency's Committee for Medicinal Products for
Human Use (CHMP) in June had recommended the approval of
caplacizumab, which is to be prescribed to adults suffering acquired
thrombotic thrombocytopenic purpura (aTTP).
The U.S Food & Drug Administration (FDA), which has granted the drug
a 'Fast Track' designation, is expected to follow suit in early
Sanofi believes some 7,500 patients present acquired TTP symptoms
across the United States, the European Union and Japan and it hopes
to launch caplacizumab in Germany later this year.
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Caplacizumab, to be marketed as Cablivi, was developed by Belgium
company Ablynx which was acquired by Sanofi earlier this year for
3.9 billion euros ($4.53 billion).
(Reporting by Matthias Blamont; Editing by Subhranshu Sahu)
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