Posted by Michael Wonder on 27 Jul 2017
Ablynx receives fast track designation from the FDA for caplacizumab for the treatment of acquired TTP
26 July 2017 - Ablynx today announced that the U.S. FDA has granted fast track designation for caplacizumab, the Company’s first-in-class anti-von Willebrand factor nanobody being developed for the treatment of acquired thrombotic thrombocytopenic purpura.
The potential of caplacizumab to address this unmet need has been demonstrated in the Phase II TITAN study which supports the marketing authorisation application submitted to the EMA in February 2017. Caplacizumab is currently being further evaluated in the randomised, double-blind, placebo-controlled Phase III HERCULES study. Results from this Phase III study will be reported in the second half of 2017 and are expected to further support the appliaction, as well as a planned filing in the United States in 2018.
