ALYGLO™ is a clean
and effective IVIG1,2

EXTRA PURIFICATION  

PROVEN EFFICACY & SAFETY  

An extra step to remove
coagulation factor XIa (FXIa)

A longstanding goal within the IG industry has been to remove FXIa, a plasma-based enzyme linked to IVIG-related thromboembolic events.2

THE STANDARD PROCESS FOR PURIFICATION

The manufacturing process for ALYGLO includes multiple steps, such as Cohn-Oncley cold ethanol fractionation, viral inactivation, and nanofiltration.2

THE CHALLENGE OF REMOVING FXIa

Because human IG and FXIa have similar isoelectric points, it can be difficult to separate FXIa from IG preparations using ethanol precipitation alone.2

CATION EXCHANGE (CEX) CHROMATOGRAPHY: ONE WAY TO REDUCE FXIa

The manufacturing process of ALYGLO uses an additional step focused on removal of FXIa.2

An extra study to confirm our technology works

  • A study was conducted to evaluate the manufacturing process of ALYGLO for its capacity to remove FXIa2
  • As part of the study, pre-CEX intermediate samples were spiked with large quantities of FXIa (32-fold and 158-fold)2
  • CEX chromatography was conducted on the spiked samples along with non-spiked samples2
  • After CEX chromatography, assays were measured to confirm FXIa levels and the results are shown below2:

PRE-CEX
INTERMEDIATE SAMPLES:

16%

coagulation FXIa remained2

AFTER CEX
CHROMATOGRAPHY:

>99%

coagulation FXIa removed2

CEX chromatography was proven to effectively reduce FXIa below detectable limits in both spiked and non-spiked samples.2

Proven protection from infection
and reduced impact on daily living

The clinical value of ALYGLO was evaluated in a prospective, open-label, multicenter, single-arm study in 33 adults with PI, aged 17-70 years. The study evaluated the efficacy, safety, and tolerability of ALYGLO.1,a

STUDY DESIGN

  • Before enrollment, all subjects were receiving stable doses between 300 and 900 mg/kg of IVIG treatment1,b
  • For 12 months, subjects received ALYGLO infusion administered every 21 or 28 days (both the dose and schedule depending on their prior therapy)
  • Primary endpoint was annualized rate of acute serious bacterial infections (ASBIs), defined as bacterial pneumonia, bacteremia/sepsis, bacterial meningitis, visceral abscess, and osteomyelitis/septic arthritis per subject per year
  • Secondary endpoint was annual rate or days of other infections, use of antibiotics, days out of work/school/daycare or unable to perform normal activities due to infection, and days of hospitalization due to infection

PRIMARY ENDPOINT
RESULTS: ASBIs1,a

0.03

Upper one-sided 99% confidence limit: 0.31, which met the predefined success rate of less than 1 ASBI per subject per year (intent-to-treat [ITT] population).

SECONDARY ENDPOINT
RESULTS1,a

2.4

other infections per patient year

6

days of missed work, school, or normal activities per year

0.2

days of hospitalization per patient year

Safety profile of ALYGLO

common adverse events (AEs)1,c

Patients reporting AEs (N=33) Infusions with AEs (N=427)
n % n %
Headache 13 39 32 7.5
Nausea/vomiting 11 33 20 4.7
Fatigue 6 18 18 4.2
Nasal/sinus congestion 5 15 5 1.2
Rash 4 12 4 0.9
Arthralgia 3 9 4 0.9
Diarrhea 3 9 3 0.7
Muscle pain/aches 2 6 7 1.6
Infusion site pain/swelling 2 6 6 1.4
Abdominal pain/discomfort 2 6 3 0.7
Cough 2 6 2 0.5
Dizziness 2 6 2 0.5
  • No adverse reactions led to withdrawal from the study1

aThe phase 3 study included both adult and pediatric populations during enrollment. However, study results and FDA approval only reflect the adult cohort.

bThe approved dosing for ALYGLO is between 300 and 800 mg/kg.

cCommon adverse events were defined as those occurring in >5% of patients.

References:

  1. ALYGLO Prescribing Information. GC Biopharma; 2023.
  2. Kang GB, Huber A, Lee J, et al. Cation exchange chromatography removes FXIa from a 10% intravenous immunoglobulin preparation. Front Cardiovasc Med. 2023;10:1253177.
+
INDICATION

ALYGLO™ is indicated for the treatment of primary humoral immunodeficiency (PI) in adults aged 17 years and older. This includes, but is not limited to, congenital agammaglobulinemia, common variable immunodeficiency (CVID), Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.

IMPORTANT SAFETY INFORMATION

WARNING: THROMBOSIS, RENAL DYSFUNCTION and ACUTE RENAL FAILURE

  • Thrombosis may occur with immune globulin intravenous (IGIV) products, including ALYGLO. Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling vascular catheters, hyperviscosity, and cardiovascular risk factors.

  • Renal dysfunction, acute renal failure, osmotic nephropathy, and death may occur with the administration of IGIV products in predisposed patients.

  • Renal dysfunction and acute renal failure occur more commonly in patients receiving IGIV products containing sucrose. ALYGLO does not contain sucrose.

  • For patients at risk of thrombosis, renal dysfunction or renal failure, administer ALYGLO at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity.

  • Contraindications: ALYGLO is contraindicated in patients who have a history of anaphylactic or severe systemic reaction to the administration of human immune globulin and in IgA-deficient patients with antibodies to IgA and a history of hypersensitivity.
  • Hypersensitivity: In case of hypersensitivity, discontinue infusion immediately and institute appropriate treatment. Epinephrine should be available for immediate treatment of severe acute hypersensitivity reactions.
  • Hyperproteinemia, Increased Serum Viscosity, and Hyponatremia: Hyperproteinemia, increased serum viscosity, and hyponatremia may occur.
  • Aseptic Meningitis Syndrome (AMS): Aseptic meningitis syndrome (AMS) may occur, especially with high doses or rapid infusion. AMS usually begins within several hours to 2 days following ALYGLO treatment. Discontinuation of treatment has resulted in remission of AMS within several days without sequelae.
  • Hemolysis: Delayed hemolytic anemia due to enhanced red blood cell (RBC) sequestration and acute hemolysis consistent with intravascular hemolysis have been reported. Cases of severe hemolysis-related renal dysfunction/failure or disseminated intravascular coagulation have occurred following infusion of IGIV. Closely monitor patients for clinical signs and symptoms of hemolysis, particularly patients with risk factors.
  • Transfusion-Related Acute Lung Injury: Noncardiogenic pulmonary edema (transfusion-related acute lung injury [TRALI]) may occur. TRALI is characterized by severe respiratory distress, pulmonary edema, hypoxemia, normal left ventricular function, and fever. Patients with TRALI may be managed using oxygen therapy with adequate ventilator support. Monitor patients for pulmonary adverse reactions.
  • Transmissible Infectious Agents: Because ALYGLO is made from human blood, it may carry a risk of transmitting infectious agents (eg, viruses, the variant Creutzfeldt-Jakob disease [vCJD] agent and, theoretically, the Creutzfeldt-Jakob disease [CJD] agent).
  • Interference with Laboratory Tests: After infusion of immunoglobulin, the transitory rise of the various passively transferred antibodies in the patient’s blood may yield positive serological testing results, with the potential for a misleading interpretation.
  • Adverse reactions (observed in ≥ 5% of study subjects) were headache, nausea/vomiting, fatigue, nasal/sinus congestion, rash, arthralgia, diarrhea, muscle pain/aches, infusion site pain/swelling, abdominal pain/discomfort, cough, and dizziness.
  • It is recommended that ALYGLO be administered separately from other drugs or medications.

For more information about ALYGLO, please see full Prescribing Information.