HYQVIA is indicated for the treatment of primary immunodeficiency (PI) in adults. HYQVIA is for subcutaneous use only. Safety and efficacy of chronic use of Recombinant Human Hyaluronidase in HYQVIA have not been established in conditions other than PI.

HYQVIA efficacy

Reliable protection.
Steady-state Ig levels.1,2

Reliable infection protection
and steady-state Ig levels.1,2

Infused every 3 or 4 weeks, HYQVIA [Immune Globulin Infusion 10%
(Human) with Recombinant Human Hyaluronidase] delivered reliable
protection against infection in the clinical study.1,2

Study design1

  • HYQVIA was studied in a prospective, open-label, non-controlled, multicenter clinical trial conducted to determine the efficacy, tolerability, and pharmacokinetics (PK) of HYQVIA in patients with primary immunodeficiency (PI). The primary outcome measure was the annualized rate of acute serious bacterial infections (ASBI), which was evaluated in 83 patients over a median treatment duration of 366 days (42 to 507 days)
  • 66 subjects who completed the efficacy clinical trial enrolled in a prospective, open-label, multicenter extension trial to assess the long-term safety and tolerability of HYQVIA. The cumulative exposure of HYQVIA across the two trials was 188 subject-years and 2,959 infusions, and a maximum exposure up to approximately 3.5 years

Patients taking once-monthly*
HYQVIA experienced:

Patients taking once-monthly HYQVIA experienced an average of .025 ASBIs per patient year with HYQVIA P<0.0001 (upper 99% CI, 0.046) Patients taking once-monthly HYQVIA experienced an average of .025 ASBIs per patient year with HYQVIA P<0.0001 (upper 99% CI, 0.046)

<1 ASBI per patient year is the threshold for substantial evidence of efficacy

  • Acute serious bacterial infections (ASBIs) included 2 episodes of pneumonia1
  • Both episodes of pneumonia were treated as outpatients with oral antibiotics.1
  • An additional episode of pneumonia requiring hospitalization occured during the ramp-up period1
Patients taking once-monthly HYQVIA experienced an average of 3.41 days off work or school per year due to infection (95% CI, 2.44-4.5)
0 days
in hospitals per year
due to infection
(95% Cl, 0.0-0.12)
Patients taking once‐monthly HYQVIA
experienced an average of 3.41 days off work or school per year due to infection (95% Cl, 2.44-4.5)
3.41
days
off work or school per
year due to infection
(95% Cl, 2.44-4.5)

*Every 3 or 4 weeks.

HYQVIA provides steady-state Ig levels between infusions1‡

Pharmacokinetic (PK) comparison between mean Ig values1‡

HYQVIA PK curve at 28 days achieved with 8% larger dose than IVIG
HYQVIA PK curve at 28 days achieved with 8% larger dose than IVIG
HYQVIA PK curve at 28 days achieved with 8% larger dose than IVIG
  • HYQVIA Ig concentration over time is similar to IVIG without the high peak
  • Peak-to-trough variation with HYQVIA is more similar to conventional SCIG
  • The mean serum IgG trough with HYQVIA was 1,077 mg/dL compared with 1,095 mg/dL with IVIG

IVIG and HYQVIA data at 28-day dosing interval.

§HYQVIA PK curve achieved with 8% larger dose than IVIG.

This graph shows a mean concentration-time plot of IgG in subjects 12 years and older. HYQVIA is not approved to treat PI in pediatric patients.

References:
  1. HYQVIA [prescribing information]. Lexington, MA: Baxalta US Inc.
  2. Food and Drug Administration. Safety, efficacy, and pharmacokinetic studies to support marketing of immune globulin intravenous (human) as replacement therapy for primary humoral immunodeficiency. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/safety-efficacy-and-pharmacokinetic-studies-support-marketing-immune-globulin-intravenous-human. Accessed May 28, 2019.