PARIS: French drugmaker Sanofi said it had secured approval in Europe for a rare blood-clotting disorder treatment using nanobodies.
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 and Drug Administration (FDA), which has granted the drug a ‘Fast Track’ designation, is expected to follow suit in early 2019.
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.
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)