Hemophilia
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Sign up freeTop drugs studied for this disease
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CLINICAL_TRIALS trial_result · 2023-04-11Clinical Trial Update: The Hemophilia Inhibitor Prevention Trial [Phase 3]
Phase 3 trial update for Hemophilia A without inhibitors; study status terminated with results posted in 2023.
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EMA approval · 2023-03-21EMA Authorised: Vihuma (simoctocog alfa) — Octapharma AB
EMA authorises Vihuma (simoctocog alfa) for Hemophilia A.
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EMA approval · 2023-03-21EMA Authorised: Nuwiq (simoctocog alfa) — Octapharma AB
The EMA authorised Nuwiq (simoctocog alfa) for Hemophilia A, with Octapharma AB as the marketing authorization holder.
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EMA withdrawal · 2023-03-02EMA Lapsed: Kogenate Bayer (octocog alfa) — Bayer AG
EMA indicates that Kogenate Bayer (octocog alfa) has lapsed (withdrawn) from regulatory status in the European market.
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EMA approval · 2023-02-27EMA Authorised: NovoSeven (eptacog alfa (activated)) — Novo Nordisk A/S
The EMA authorised NovoSeven (eptacog alfa activated) from Novo Nordisk A/S for multiple indications including Hemophilia A/B, Factor VII de…
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CLINICAL_TRIALS trial_result · 2023-02-21Clinical Trial Update: The Hemophilia Inhibitor Eradication Trial [Phase 3]
Phase 3 trial in Hemophilia A with inhibitor was terminated; results posted in 2023.
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CLINICAL_TRIALS trial_result · 2023-02-15Clinical Trial Update: Impact of Moderate Intensity Physical Activities on PK-guided EHL FVIII Concentrates Prophylaxis Severe HA Patients [Phase 4]
Phase 4 trial assessing how moderate-intensity physical activity affects PK-guided extended half-life factor VIII concentrates for prophylax…
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CLINICAL_TRIALS trial_result · 2023-02-06Clinical Trial Update: A Study of Fitusiran in Severe Hemophilia A and B Patients Previously Receiving Factor or Bypassing Agent Prophylaxis [Phase 3]
Phase 3 trial evaluating fitusiran in severe hemophilia A and B patients previously on factor or bypassing agent prophylaxis has completed w…
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CLINICAL_TRIALS trial_result · 2022-12-15Clinical Trial Update: A Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of Emicizumab in Participants With Mild or Moderate Hemophilia A Without FVIII Inhibitors [Phase 3]
Phase 3 study evaluating safety, efficacy, pharmacokinetics and pharmacodynamics of emicizumab in people with Hemophilia A without FVIII inh…
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CLINICAL_TRIALS trial_result · 2022-12-02Clinical Trial Update: A Factor IX Gene Therapy Study (FIX-GT) [Phase 1, Phase 2]
A phase 1/2 clinical trial of a Factor IX gene therapy (FIX-GT) for Hemophilia B was terminated; results were posted in 2022.
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EMA approval · 2022-11-29EMA Authorised: Cevenfacta (Eptacog beta (activated)) — Laboratoire Francais du Fractionnement et des Biotechnologies
The EMA authorised Cevenfacta (eptacog beta activated) for treatment of bleeding in Hemophilia A and B.
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FDA approval · 2022-11-16FDA Approved: DESMOPRESSIN ACETATE — Original Application (Fresenius Kabi USA, LLC)
FDA approved the Original Application for Desmopressin Acetate from Fresenius Kabi USA, LLC (ANDA216922). This marks the approval of a gener…
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CLINICAL_TRIALS trial_result · 2022-10-10Clinical Trial Update: HOPE-B: Trial of AMT-061 in Severe or Moderately Severe Hemophilia B Patients [Phase 3]
The HOPE-B Phase 3 trial of AMT-061 (fidanacogene elaparvovec) for Hemophilia B has completed, with results posted in October 2022.
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EMA withdrawal · 2022-09-27EMA Application withdrawn: HemAryo (eptacog alfa (activated)) — UGA Biopharma
EMA withdrawn the application for HemAryo (eptacog alfa activated) by UGA Biopharma for hemophilia A, hemophilia B, and factor VII deficienc…
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CLINICAL_TRIALS trial_result · 2022-08-30Clinical Trial Update: RIXUBIS PMS India (RIXUBIS PMS) [Phase 4]
Phase 4 trial update for RIXUBIS in Hemophilia B; study completed with results posted.
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FDA approval · 2022-08-19FDA Approved: DESMOPRESSIN ACETATE — Original Application (Dr. Reddy's Laboratories Inc.)
FDA approved Desmopressin Acetate from Dr. Reddy's Laboratories Inc. via an Original Application for a generic product.
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CLINICAL_TRIALS trial_result · 2022-08-04Clinical Trial Update: Clinical Study of Recombinant Human Activated Coagulation Factor VII for Injection in Patients With Hemophilia With Inhibitor [Phase 3]
Phase 3 clinical study evaluating recombinant human activated coagulation factor VII for injection in patients with hemophilia with inhibito…
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CLINICAL_TRIALS trial_result · 2022-07-20Clinical Trial Update: Clinical Outcomes of Low Dose PK-guided EHL FVIII Concentrates Versus Standard Prophylaxis in Severe Haemophilia A [Phase 4]
A Phase 4 trial comparing low-dose PK-guided extended-half-life FVIII concentrates to standard prophylaxis in adults with severe Hemophilia …
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CLINICAL_TRIALS trial_result · 2022-07-14Clinical Trial Update: A Safety and Efficacy Extension Study of a Recombinant Fusion Protein Linking Coagulation Factor IX With Albumin (rIX-FP) in Patients With Hemophilia B [Phase 3]
A Phase 3 extension study evaluated the safety and efficacy of rIX-FP in patients with Hemophilia B.
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CLINICAL_TRIALS trial_result · 2022-07-01Clinical Trial Update: A Study to Evaluate the Safety and Efficacy of VGB-R04 in Adult Hemophilia B Patients [Phase 1, Phase 2]
A study evaluating the safety and efficacy of VGB-R04 in adults with Hemophilia B is currently in Phase 1/2 with unknown status.
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CLINICAL_TRIALS trial_result · 2022-06-27Clinical Trial Update: Trial of AAV5-hFIX in Severe or Moderately Severe Hemophilia B [Phase 1, Phase 2]
Phase 1/2 trial of AAV5-hFIX in severe or moderately severe Hemophilia B has completed; results posted in 2022.
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EMA approval · 2022-06-24First gene therapy to treat severe haemophilia A
The European Medicines Agency announces the first gene therapy approved to treat severe haemophilia A, marking a landmark advancement in cur…
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FDA approval · 2022-06-23FDA Approved: TRANEXAMIC ACID — Supplemental Application (Mylan Institutional LLC)
FDA approved a supplemental application for tranexamic acid submitted by Mylan Institutional LLC. This action authorizes the continued comme…
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CLINICAL_TRIALS trial_result · 2022-06-16Clinical Trial Update: Dose Confirmation Trial of AAV5-hFIXco-Padua [Phase 2]
Phase 2 dose confirmation trial of AAV5-hFIXco-Padua for Hemophilia B has completed and results have been posted.
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CLINICAL_TRIALS trial_result · 2022-06-09Clinical Trial Update: Safety Study of Alphanate in Previously Treated Patients With Severe Hemophilia A [Phase 4]
This is a Phase 4 safety study of Alphanate in previously treated patients with severe Hemophilia A. Results have been posted.