Feb 6, 2019: The U.S. Food and Drug Administration (FDA) has approved Cablivi® (caplacizumab-yhdp) in combination with plasma exchange and immunosuppression for the treatment of acquired thrombotic thrombocytopenic purpura (aTTP) in adults. Cablivi is the first FDA approved therapy specifically indicated for the treatment of aTTP. Full press release here.
January 9, 2019: New England Journal of Medicine publishes results of caplacizumab double-blind, controlled trial of 145 patients with TTP. "CONCLUSIONS: Among patients with TTP, treatment with caplacizumab was associated with faster normalization of the platelet count; a lower incidence of a composite of TTP-related death, recurrence of TTP, or a thromboembolic event during the treatment period; and a lower rate of recurrence of TTP during the trial than placebo". Journal article link here.
October 2, 2017 ABLYNX "announced positive topline results from the Phase III HERCULES study with caplacizumab, the Company's anti-von Willebrand factor (vWF) Nanobody® being developed for the treatment of acquired thrombotic thrombocytopenic purpura (aTTP)." View the full article.
July 26, 2017: Ablynx announced "that the Food and Drug Administration (FDA) has granted Fast Track designation for caplacizumab for the treatment of acquired thrombotic thrombocytopenic purpura (aTTP)." SOURCE: http://www.empr.com/drugs-in-the-pipeline/caplacizumab-attp-autoimmune-b....View the full article.