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About HYMPAVZIAbout
HYMPAVZIOverviewHYMPAVZI in ActionEfficacyEfficacyStudy DesignPrimary EndpointsSecondary EndpointsSafetyDosing & AdminDosing 

& AdminDosingPen OverviewInjection OverviewPatient StoriesPatient
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BASIS Study and OLE Study designs

The efficacy and safety of HYMPAVZI were evaluated in the Phase 3 BASIS Study, with an open-label extension (OLE) study performed for up to an additional 30 months.1,2

Participants in the BASIS Study, a Phase 3 study1,3

BASIS Study Description: The BASIS Study was a Phase 3 study including 116 patients 12 to <75 years of age with severe hemophilia A without inhibitors or moderately severe to severe hemophilia B without inhibitors. The primary efficacy endpoint was ABR of treated bleeds after 12 months of HYMPAVZI prophylaxis treatment vs on-demand factor-based treatment and vs routine factor-based prophylaxis treatment.1

Patients enrolled were from a diverse study population3

Select inclusion criteria1:

  • Adult and adolescent males 12+ years of age and ≥35 kg (~77 lb)
  • Severe hemophilia A without inhibitors or moderately severe to severe hemophilia B without inhibitors

Select exclusion criteria1:

  • Current treatment for/history of coronary artery disease, venous or arterial thrombosis, or ischemic disease

Additional patient characteristics1,3:

HYMPAVZI was studied in patients with a high proportion of baseline target joints. 128 patients were enrolled in the BASIS Study, and 116 patients completed the active treatment phase of the BASIS Study.1,3BASIS Study select endpoints1

ABRs were evaluated after 12 months of HYMPAVZI prophylaxis treatment vs

  • On-demand factor-based treatment
  • Routine factor-based prophylaxis treatment
After 12 months of treatment with HYMPAVZI1,3: ReferencesABR=annualized bleed rate; ADA=anti-drug antibody; NAb=neutralizing antibody.See BASIS Study resultsLoadingOLE Study design1,2

OLE Study Description: Following the 12-month active treatment period, 107 (92%)† patients who completed the BASIS Study continued using HYMPAVZI during an OLE study. Efficacy endpoints included ABR of treated bleeds and were measured up to an additional 30 months.‡

Eligibility Criteria

Following the 12-month active treatment period, patients who completed the BASIS Study were eligible to enroll in an OLE Study (NCT05145127).1,2

107 (92%) eligible patients continued into the OLE Study using HYMPAVZI.2

Safety

To determine the safety and tolerability of long-term treatment with HYMPAVZI in participants 12 to <75 years of age with severe hemophilia A or moderately severe to severe hemophilia B (FVIII activity <1% or FIX activity ≤2%, respectively) with or without inhibitors.4

Select safety endpoints4:

  • Adverse events
  • Serious adverse events
  • Incidence and severity of thrombotic events
  • Incidence and severity of thrombotic microangiopathy
  • Disseminated intravascular coagulation/consumption coagulopathy

Efficacy Endpoints2

In the OLE Study, ABR of HYMPAVZI prophylaxis treatment was compared vs

  • On-demand factor-based treatment
  • Routine factor-based prophylaxis treatment
 All patients who completed the Phase 3 BASIS Study and enrolled into the OLE Study on or before April 13, 2024, are included in this dataset.2The median ABR is a descriptive summary.2BASIS Study and OLE Study trial timeline1,2 A dose adjustment to 300 mg subcutaneous injection weekly was permitted in patients weighing ≥50 kg when control of bleeding events was judged to be inadequate by the healthcare provider. Safety and efficacy of HYMPAVZI at doses above 300 mg weekly have not been established.1Median follow-up 18.9 months.2See the OLE Study resultsLoadingReferences:1. HYMPAVZI. Prescribing Information. Pfizer Inc.; 2025. 2. Data on file. Pfizer Inc.; 2025. 3. Matino D, et al. Blood. 2025. doi:10.1182/blood.2024027468 4. ClinicalTrials.gov. Published 2024. Accessed January 7, 2026. https://clinicaltrials.gov/study/NCT05145127Efficacy Consistent protection

Comparison of ABR of treated bleeds with HYMPAVZI vs on-demand factor-based treatment and vs routine factor-based prophylaxis treatment1

See primary endpointsLoading

HYMPAVZI is a registered trademark of Pfizer Inc.

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PP-HYM-USA-0601
Indications and usageHYMPAVZI is indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients 12 years of age and older with:
  • hemophilia A (congenital factor VIII deficiency) without factor VIII inhibitors, or
  • hemophilia B (congenital factor IX deficiency) without factor IX inhibitors.
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Important Safety InformationVenous thrombotic events were reported in clinical studies with HYMPAVZI. Patients with independent risk factors for thromboembolic events may be at increased risk of thromboembolic events with use of HYMPAVZI. Consider the benefit and risk of using HYMPAVZI in patients with known risk factors for thromboembolism. Interrupt HYMPAVZI prophylaxis if diagnostic findings consistent with thromboembolism occur and manage as clinically indicated. If factor VIII or factor IX products are indicated in a patient receiving HYMPAVZI prophylaxis, the minimum effective dose of factor VIII or factor IX according to the product label is recommended.

HYMPAVZI may cause hypersensitivity reactions (including, but not limited to, urticaria and pruritus). If HYMPAVZI-treated patients develop a severe hypersensitivity reaction, advise patients to discontinue HYMPAVZI and seek immediate emergency treatment.

Based on its mechanism of action, HYMPAVZI may cause fetal harm when administered to a pregnant woman. Verify that females of reproductive potential are not pregnant prior to initiating HYMPAVZI. Advise pregnant women of the potential risk to the fetus. Advise females of reproductive potential to use effective contraception during treatment with HYMPAVZI and for 2 months after the last dose.

A serious adverse reaction of peripheral swelling occurred in one patient. A serious adverse reaction of venous thrombosis occurred in 0.9% of patients (1/116) in the open-label extension study. Adverse reactions reported in ≥3% of patients treated with HYMPAVZI in clinical trials included injection site reaction (9% of patients); headache (7% of patients); pruritus (3% of patients).IndicationsHYMPAVZI is indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients 12 years of age and older with:
  • hemophilia A (congenital factor VIII deficiency) without factor VIII inhibitors, or
  • hemophilia B (congenital factor IX deficiency) without factor IX inhibitors.