March 2, 2020: Caplacizumab has been approved by Health Canada for the treatment of adults with aTTP in combination with plasma echange and immunosuppressive therapy. Answering TTP Foundation is looking forward to working with provincial and territorial partners to ensure that this therapy is quickly made available at TTP treatment centers across the country and receives timely reimbursement by public and private plans.
December 2019: Caplacizumab is in the process of being reviewed (by
CADTH and
INESSS), and recommendations made to Canadian decision makers regarding approval for use and funding. All those diagnosed with TTP were encouraged to help provide the patient perspective to aid decision makers by taking part in two community surveys. The results of the surveys were used to complete
patient feedback and followup question forms. More information about the review of caplacizumab
and copies of submissions can be found on the
CADTH website here.
October 2019: After reading our anonymous patient feedback submission to the Common Drug Review process, decision makers have asked to know more about the experiences of patients receiving plasma exchange and/or steroids for the treatment of TTP. Please complete this short
survey TODAY and pass it along to any other TTP patients!
July 2019: All those diagnosed with TTP (anywhere in the world) are encouraged to help provide the patient perspective to aid decision makers by taking part in the
2019 TTP Community Survey ASAP (complete and closed) or by August 12, 2019. Cablivi will shortly be reviewed (by
CADTH and
INESSS), and recommendations made to Canadian decision makers regarding approval for use and funding.
Cablivi
® (caplacizumab-yhdp) is the first medicine approved in the U.S. specifically for the treatment of aTTP. The drug was studied in a multicentre, randomized, double-blind, placebo-controlled Phase 3 clinical study known as HERCULES. Study conclusions were published in the New England Journal of Medicine in January 2019. "
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"---source: New England Journal of Medicine.
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.
