concizumab

06/02/2014 - "The clearance of concizumab was estimated to be 0.14 ml/h/kg, the target clearance was characterized by a 50% saturation level of 0.54 μg/ml (Km), and the clearance at target saturation was estimated to be 11 μg/h/kg. Concizumab displays a typical TMDD profile with important implications for a putative treatment regime in haemophilia patients. "
12/01/2021 - "On the basis of this mechanism of action, concizumab is expected to be equally effective in hemophilia A and B, regardless of inhibitor status. "
08/31/2023 - "We conducted the explorer7 trial to assess the safety and efficacy of concizumab in patients with hemophilia A or B with inhibitors. "
08/31/2023 - "A previous trial of concizumab (explorer4) established proof of concept in patients with hemophilia A or B with inhibitors. "
08/31/2023 - "Phase 3 Trial of Concizumab in Hemophilia with Inhibitors."

01/01/2022 - "Both trials included main (≥24 weeks) and extension (52-102 weeks) parts, with patients receiving concizumab 0.15 mg/kg with potential dose escalation to concizumab 0.20 or 0.25 mg/kg if they experienced ≥3 treated spontaneous bleeding episodes within 12 weeks. "
08/31/2023 - "The overall median annualized bleeding rate for patients receiving concizumab (groups 2, 3, and 4) was 0 episodes. "
11/28/2019 - "Patients received 0.15 mg/kg concizumab, with potential dose escalation to 0.20 and 0.25 mg/kg (if ≥3 spontaneous bleeding episodes within 12 weeks of concizumab treatment). "
01/01/2019 - "A correlation between bleeding episode frequency and concizumab concentration was indicated; patients with a concizumab concentration >100 ng/mL experienced less frequent bleeding. "
06/14/2012 - "Cuticle bleeding in the model was reduced for at least 7 days by a single intravenous dose of mAb 2021. "

08/31/2023 - "After a treatment pause due to nonfatal thromboembolic events in three patients receiving concizumab, including one from the explorer7 trial, concizumab therapy was restarted with a loading dose of 1.0 mg per kilogram of body weight, followed by 0.2 mg per kilogram daily (potentially adjusted on the basis of concizumab plasma concentration as measured at week 4). "

07/01/2023 - "This article summarizes the milestones in the development of concizumab leading to this first approval for the treatment of hemophilia B."
12/01/2021 - "On the basis of phase 2 results, the US Food and Drug Administration granted concizumab Breakthrough Therapy designation for hemophilia B with inhibitor patients, a rare and vulnerable patient subgroup that currently has the highest unmet medical need. "
07/01/2023 - "In March 2023, concizumab was approved in Canada for the treatment of adolescent and adult patients (12 years of age or older) with hemophilia B who have FIX inhibitors and require routine prophylaxis to prevent or reduce the frequency of bleeding episodes. "