Wednesday, February 6, 2019

Sanofi blood disorder drug wins FDA approval

(Reuters) - The U.S. Food and Drug Administration (FDA) said on Wednesday it had approved Sanofi SA’s drug to treat a rare blood-clotting disorder in adults in combination with standard-of-care treatments.


The treatment, called Cablivi, is already approved in the European Union as a treatment for acquired forms of the disorder, called thrombotic thrombocytopenic purpura.


Cablivi should come with a warning about the risk of severe bleeding, the FDA said.




Reporting by Manogna Maddipatla in Bengaluru; Editing by Sai Sachin Ravikumar




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