PharmaRadar360

PharmaRadar360

HematologyDrug intelligence

Hemlibra

Emicizumab

Bispecific antibody bridging factor IXa and factor X. Developed by Roche. Clinical, regulatory, and source evidence are connected below.

Company
Roche
Target / MOA
Factor IXa 路 Factor X
Aliases
Hemlibra 路 ACE910
Signals
21
Clinical trials
17
Approvals
1
Evidence sources
21

Latest signals

What changed

The three most recent source-backed changes linked to this drug.

clinical trialClinicalTrials.gov

A Study to Assess the Efficacy and Safety of Emicizumab in Participants With Type 3 Von Willebrand Disease

Phase 3 路 RECRUITING 路 Hoffmann-La Roche

clinical trialClinicalTrials.gov

A Clinical Study to Evaluate the Effects of NXT007 Compared to Emicizumab Prophylaxis in People With Hemophilia A

Phase 3 路 RECRUITING 路 Hoffmann-La Roche

clinical trialClinicalTrials.gov

A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Subcutaneous Emicizumab in Participants From Birth to 12 Months of Age With Hemophilia A Without Inhibitors

Phase 3 路 ACTIVE_NOT_RECRUITING 路 Hoffmann-La Roche

Approved uses

What regulators have approved

The indications section of each current US label, word for word, and the EU summary of each authorised product. Official sources as of Oct 18, 2026.

United States (FDA label)

Hemlibra 路 BLA761083 路 label version 17, effective Jul 11, 2025 路 DailyMed

Label section 1

1 INDICATIONS AND USAGE HEMLIBRA is indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients ages newborn and older with hemophilia A (congenital factor VIII deficiency) with or without factor VIII inhibitors.

European Union (EMA)

Hemlibra 路 EMEA/H/C/004406 路 Authorised, authorised Feb 23, 2018 (Commission decision C(2018) 1282) 路 EPAR

Hemlibra is indicated for routine prophylaxis of bleeding episodes in patients with haemophilia A (congenital factor VIII deficiency): with factor VIII inhibitors without factor VIII inhibitors who have: severe disease (FVIII < 1%) moderate disease (FVIII ? 1% and ? 5%) with severe bleeding phenotype. Hemlibra can be used in all age groups.

EMA's summary; the full indication is in the product information on the EPAR page.

Regulatory history

Approvals over time

US original approvals and efficacy supplements (new indications, populations or dosing) from Drugs@FDA; EU authorisations and CHMP opinions on extensions. Official sources as of Oct 18, 2026.

United States

BLA761083 路 GENENTECH INC 路 first approved Nov 16, 2017

2 efficacy supplements approved

European Union

  • Hemlibra: Authorised since Feb 23, 2018

Patents and exclusivity

What FDA lists (US)

Patents and exclusivity as FDA lists them in the Orange Book (drugs) and the Purple Book (biologics), with approved generics and biosimilars. Expired listings are not shown. Official sources as of Oct 18, 2026.

BLA761083 (Purple Book)

No exclusivity date listed.

Generics and biosimilars

The Purple Book lists no licensed biosimilar.

FDA's listings only: an approved generic or licensed biosimilar may not be on the market yet. Not a forecast of when they may launch, and not legal advice.

Safety

Boxed warnings and FDA safety communications

The boxed warning on each current US label, and FDA Drug Safety Communications that name the drug (FDA's list from January 2020). Official sources as of Oct 18, 2026.

Boxed warning

Hemlibra label

WARNING: THROMBOTIC MICROANGIOPATHY AND THROMBOEMBOLISM Cases of thrombotic microangiopathy and thrombotic events were reported when on average a cumulative amount of >100 U/kg/24 hours of activated prothrombin complex concentrate was administered for 24 hours or more to patients receiving HEMLIBRA prophylaxis. Monitor for the development of thrombotic microangiopathy and thrombotic events if aPCC is administered. Discontinue aPCC and suspend dosing of HEMLIBRA if symptoms occur.

FDA Drug Safety Communications

None on FDA's list names this drug.

Clinical trials

Key active studies

A focused view of recently updated studies 路 17 linked records.

Phase 3RECRUITINGNCT06998524

A Study to Assess the Efficacy and Safety of Emicizumab in Participants With Type 3 Von Willebrand Disease

Hoffmann-La Roche 路 Updated Oct 9, 2026

Phase 3RECRUITINGNCT07416604

A Clinical Study to Evaluate the Effects of NXT007 Compared to Emicizumab Prophylaxis in People With Hemophilia A

Hoffmann-La Roche 路 Updated Oct 6, 2026

Phase 3ACTIVE NOT RECRUITINGNCT04431726

A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Subcutaneous Emicizumab in Participants From Birth to 12 Months of Age With Hemophilia A Without Inhibitors

Hoffmann-La Roche 路 Updated Oct 1, 2026

Phase 3COMPLETEDNCT04158648

A Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of Emicizumab in Participants With Mild or Moderate Hemophilia A Without FVIII Inhibitors

Hoffmann-La Roche 路 Updated Aug 27, 2026

Phase 3RECRUITINGNCT04563520

SAFE Study: Safety of aPCC Following Emicizumab Prophylaxis

Emory University 路 Updated Aug 21, 2026

Phase 4ACTIVE NOT RECRUITINGNCT05181618

A Study to Evaluate Overall Health, Physical Activity, and Joint Outcomes in Participants With Severe or Moderate Hemophilia A Without Factor VIII Inhibitors on Emicizumab Prophylaxis

Hoffmann-La Roche 路 Updated Jul 27, 2026

Source evidence

Where this profile comes from

Facts link back to original registries, regulators, labels, and publishers. Counts change as source records update.

ClinicalTrials.govofficial 路 Latest Oct 9, 202620FDAofficial 路 Latest Jul 8, 20251
Professional referenceThis profile summarizes linked public evidence. It is not medical, legal, regulatory, or investment advice. Verify decisions against original sources.