- HYQVIA [Immune Globulin Infusion 10% (Human) with
Recombinant Human Hyaluronidase] becomes the Only Facilitated
Subcutaneous Immunoglobulin, Offering Patients an up to
Once-Monthly Treatment Option
- At-Home or In-Office Administration Provides CIDP Patients
with a Personalized Treatment Experience
- Approval Expands Takeda’s Portfolio of Differentiated
Immunoglobulin Therapies for Patients with Neuroimmunological
Disorders
Takeda (TSE:4502/NYSE:TAK) today announced that the
European Commission (EC) approved HYQVIA® [Immune Globulin Infusion
10% (Human) with Recombinant Human Hyaluronidase] as maintenance
therapy in patients of all ages with chronic inflammatory
demyelinating polyneuropathy (CIDP) after stabilization with
intravenous immunoglobulin therapy (IVIG). Takeda previously
announced a positive opinion from the Committee for Medicinal
Products for Human Use (CHMP) on December 15, 20231 and approval as
a maintenance therapy for adults with CIDP by the U.S. Food and
Drug Administration on January 16, 2024.2
As the first and only facilitated subcutaneous immunoglobulin
(fSCIG) for CIDP, HYQVIA offers the potential for patients to
infuse up to once monthly (every two, three or four weeks), as the
hyaluronidase component facilitates the dispersion and absorption
of large immunoglobulin (IG) volumes in the subcutaneous space
between the skin and the muscle. HYQVIA can be administered by a
healthcare professional or self-administered in the comfort of a
patient’s own home after appropriate training.3
“Following the FDA approval of the HYQVIA CIDP indication in
January 2024, the EC’s approval of HYQVIA for CIDP is a critical
step towards giving people in the EU living with CIDP access to a
maintenance treatment with proven efficacy that can be administered
up to once monthly, at-home or in-office,” said Kristina Allikmets,
senior vice present and head of Research & Development for
Takeda’s Plasma-Derived Therapies Business Unit. “This expanded
indication for HYQVIA also reflects Takeda’s commitment to bring
the benefits of our immunoglobulin therapies to people with
neuroimmunological disorders and provide treatment options that
have the potential to positively impact their lives and elevate the
standard of care.”
CIDP is an acquired, immune-mediated condition affecting the
peripheral nervous system that is characterized by progressive,
symmetric weakness in distal and proximal limbs and impaired
sensory function in the extremities.4 The role of IG therapy for
this rare, debilitating and slowly progressing or relapsing disease
has been well-established5 and is considered a standard of care for
this complex and heterogeneous condition in guidelines from the
European Academy of Neurology and Peripheral Nerve Society due to
its broad immunomodulatory and anti-inflammatory effects.6
This approval is based on data from the pivotal Phase 3
ADVANCE-CIDP 1 trial, which was a multicenter, placebo-controlled,
double-blinded study that evaluated the efficacy and safety of
HYQVIA as a maintenance therapy to prevent relapse in patients with
CIDP. The global study included 132 adults with a confirmed
diagnosis of CIDP who had remained on a stable dosing regimen of
IVIG therapy for at least three months prior to screening. Results
showed a clinically significant reduction in CIDP relapse rate with
HYQVIA versus placebo 15.5% (95% CI: 8.36, 26.84) in the HYQVIA and
31.7% (95% CI: 21.96, 43.39) in the placebo groups. The treatment
difference was -16.2 (95% CI: -29.92, -1.27), favoring HYQVIA over
placebo.3
While adverse events (AEs) were more frequent with HYQVIA (79.0%
of patients) than placebo (57.1%), severe (1.6% vs 8.6%) and
serious AEs (3.2% vs 7.1%) were less common. The majority of AEs
were mild or moderate, local, did not require suspension of
infusions, and resolved without sequelae. The most common (reported
in >5% of patients) causally related AEs included headache and
nausea, as well as local AEs including infusion site pain,
erythema, pruritis, and edema. 7 Overall, the safety profile
observed in the ADVANCE-CIDP 1 trial was generally consistent with
the existing EU Summary of Product Characteristics (SmPC).3
The centralized marketing authorization for HYQVIA in CIDP is
valid in all EU member states as well as in Iceland, Liechtenstein,
Norway and Northern Ireland. HYQVIA first received approval from
the EC for the treatment of primary immunodeficiency (PID) in 2013
as well as secondary immunodeficiency (SID) in 2020.8
About HYQVIA®
HYQVIA® [Immune Globulin Infusion 10% (Human) with Recombinant
Human Hyaluronidase] is a liquid medicine containing Recombinant
Human Hyaluronidase and immunoglobulins (IG) and is approved by the
European Medicines Agency (EMA) as a replacement therapy in adults,
children and adolescents with primary immunodeficiency (PI) and
with secondary immunodeficiency (SID) who suffer from severe or
recurrent infections, ineffective antimicrobial treatment, and
either proven specific antibody failure (PSAF) or serum IgG level
of <4 g/L. In addition, it is approved by the EMA as maintenance
therapy in adults, children and adolescents (0-18 years) with
chronic inflammatory demyelinating polyneuropathy (CIDP) after
stabilization with intravenous immunoglobulin therapy (IVIG). In
the United States it is approved to treat adults and children two
years of age and older with PI as a well as a maintenance therapy
for adult patients with CIDP. HYQVIA is infused under the skin into
the fatty subcutaneous tissue. HYQVIA contains IG collected from
human plasma. IG are antibodies that maintain the body’s immune
system. The hyaluronidase part of HYQVIA facilitates the dispersion
and absorption of IG in the subcutaneous space between the skin and
the muscle. HYQVIA is infused up to once a month (every two, three
or four weeks for CIDP; every three or four weeks for PI).
About the ADVANCE Clinical Program
ADVANCE-CIDP 1 was a Phase 3, multicenter, placebo-controlled,
double-blinded study to evaluate the efficacy, safety and
tolerability of HYQVIA® [Immune Globulin Infusion 10% (Human) with
Recombinant Human Hyaluronidase] as a maintenance therapy to
prevent relapse in chronic inflammatory demyelinating
polyneuropathy (CIDP). The global study included 132 adults with a
confirmed diagnosis of CIDP and who had remained on a stable dosing
regimen of intravenous immunoglobulin (IVIG) therapy for at least
three months prior to screening.
The primary endpoint of the clinical trial was the proportion of
subjects who experienced a worsening of functional disability,
defined as an increase of ≥1 point relative to the pre-subcutaneous
(SC) treatment baseline score in two consecutive adjusted
Inflammatory Neuropathy Cause and Treatment (INCAT) disability
scores. The primary efficacy analysis compared relapse rates using
a continuity-corrected χ2 test conducted at the 5% level of
statistical significance, with missing data imputed as no relapse.
Some of the secondary endpoints included time to relapse as defined
by relapse probability, effect on activities of daily living (ADL),
safety and tolerability. Patients were randomized to receive either
HYQVIA or placebo at the same dose and infusion frequency as their
prior IVIG treatment (every two, three or four weeks) for six
months or until relapse. Patients who relapsed were offered IVIG
treatment as rescue therapy for a period of up to six months. Those
who remained relapse free were offered to continue HYQVIA treatment
as part of ADVANCE-CIDP 3, an open-label extension clinical trial
to assess the long-term safety, tolerability and immunogenicity of
HYQVIA in participants with CIDP who completed ADVANCE-CIDP 1.
Further information about the ADVANCE-CIDP 1 clinical trial is
available at ClinicalTrials.gov under study identifier
NCT02549170.
HyQvia® (Human normal immunoglobulin) 100 mg/ml solution for
infusion for subcutaneous use PRESCRIBING INFORMATION
Always refer to the Summary of Product
Characteristics (SmPC) and the local prescribing information
of your country before prescribing.
Presentation: HyQvia is a
dual vial unit consisting of one vial of 10% human normal
immunoglobulin (Ig) and one vial of recombinant human hyaluronidase
(see the SmPC for details).
Indications: Replacement therapy in adults, children and adolescents
(0-18 years) in: primary immunodeficiency syndromes (PID)
with impaired antibody production; secondary immunodeficiencies
(SID) in patients who suffer from severe or recurrent infections,
ineffective antimicrobial treatment and either proven specific
antibody failure (PSAF) or serum IgG level of <4 g/l. PSAF is a
failure to mount at least a 2-fold rise in IgG antibody titre to
pneumococcal polysaccharide and polypeptide antigen vaccines.
Immunomodulatory therapy in adults, children
and adolescents (0 to 18 years) in: chronic inflammatory
demyelinating polyneuropathy (CIDP) as maintenance therapy after
stabilization with IVIg.
Dosage and administration:
For subcutaneous use only. Therapy should be initiated and
monitored under the supervision of a physician experienced in the
treatment of immunodeficiency/CIDP. The product should be brought
to room temperature before use. Inspect both vials for
discolouration and particulate matter before administration. Do not
use heating devices including microwaves. Do not shake or mix the
components of the two vials. Suggested infusion site(s) are the
middle to upper abdomen and thighs. The two components of the
medicinal product must be administered sequentially through the
same needle beginning with the recombinant human hyaluronidase
followed by Ig 10%. Please see the SmPC for infusion rates. The
full contents of the recombinant human hyaluronidase vial should be
administered regardless of whether the full contents of the Ig 10%
vial is administered. Longer needles may be used under medical
supervision to prevent infusion site leakage. Home treatment should
be initiated and monitored by a physician experienced in the
guidance of patients for home treatment. Posology: Dose and dosage regimen may need to be
individualised for each patient dependent on the response. The dose
and dose regimens are dependent on the indication. Dose based on
body weight may require adjustment in underweight or overweight
patients. Replacement therapy in PID:
Patients naïve to Ig therapy: The dose required to achieve a trough
level of 6 g/L is approximately 0.4-0.8 g/kg body weight/month. The
dose interval to maintain steady state levels varies from 2-4
weeks. IgG trough levels should be measured and assessed in
conjunction with the incidence of infection. To reduce the rate of
infection, it may be necessary to increase the dose and aim for
higher trough levels (>6 g/l). At the initiation of therapy, it
is recommended that the treatment intervals for the first infusions
be gradually prolonged from a 1-week dose to up to a 3- or 4-week
dose. Patients previously treated with intravenous (IV) Ig: For
patients switching directly from IV Ig, or who have had a previous
IV dose that can be referenced, the medicinal product should be
administered at the same dose and at the same frequency as their
previous IV Ig treatment. Patients previously treated with Ig
administered subcutaneously: the initial dose of HyQvia is the same
as for subcutaneous treatment but may be adjusted to 3- or 4-week
intervals. The first infusion should be given one week after the
last treatment with the previous Ig. Replacement therapy in SID:
the recommended dose is 0.2-0.4 g/kg every 3 to 4 weeks. IgG levels
should be measured and assessed in conjunction with the incidence
of infection. Dose should be adjusted as necessary to achieve
optimal protection against infections, an increase may be necessary
in patients with persisting infection; a dose decrease can be
considered when the patient remains infection free. Immunomodulatory therapy in CIDP: Before
initiating therapy, the weekly equivalent dose should be calculated
by dividing the planned dose by the planned dose interval in weeks.
The typical dosing interval range for HyQvia is 3 -to 4 - weeks.
The recommended subcutaneous dose is 0.3 to 2.4 g/kg body weight
per month, administered in 1-or 2-sessions over 1-or 2-days. The
patient`s clinical response should be the primary consideration in
dose adjustment. The dose may need to be adapted to achieve the
desired clinical response. In clinical deterioration, the dose may
be increased to the recommended maximum of 2.4 g/kg monthly. If the
patient is clinically stable, periodic dose reductions may be
needed to observe whether the patient still needs IG therapy. A
titration schedule that permits gradual dose increase over time
(ramp-up) is recommended to ensure the patient’s tolerability until
the full dose is reached. During the titration schedule, the
calculated HyQvia dose and recommended dose intervals must be
followed for the first and second infusions. Depending on the
treating physician's discretion, in patients who tolerate the first
2 infusions well, subsequent infusions may be administered by
gradually increasing doses and dose intervals, considering the
volume and total infusion time. An accelerated titration schedule
may be considered if the patient tolerates the SC infusion volumes
and the first 2 infusions. Doses less than or equal to 0.4 g/kg may
be administered without a titration schedule, provided acceptable
patient tolerance. Patients must be on stable doses (Variations in
the dosing interval of up to ±7 days or monthly equivalent dose
amount of up to ±20% between the subject’s IgG infusions are
considered a stable dose) of IVIg. Before initiating therapy with
the medicinal product, the weekly equivalent dose should be
calculated by dividing the last IVIg dose by the IVIg dose interval
in weeks. The starting dose and dosing frequency are the same as
the patient’s previous IVIg treatment. The typical dosing interval
for HyQvia is 4-weeks. For patients with less frequent IVIg dosing
(greater than 4-weeks), the dosing interval can be converted to
4-weeks while maintaining the same monthly equivalent IgG dose. The
calculated one-week dose (1st infusion) should be administered 2 -
weeks after the last IVIg infusion (see Table 1 of the SmPC). One
week after the first dose, the next weekly equivalent dose (2nd
infusion) should be administered. A titration schedule can take up
to 9-weeks (see Table 1 of the SmPC), depending on the dosing
interval and tolerability. On a given infusion day, the maximum
infusion volume should not exceed 1200 mL for patients weighing ≥40
kg or 600 mL for <40 kg. Suppose the maximum daily dose limit is
exceeded or the patient cannot tolerate the infusion volume. In
that case, the dose may be administered over multiple days in
divided doses with 48-to 72-hours between doses to allow absorption
of infusion fluid at the infusion site(s). The dose can be
administered up to 3 infusion sites with a maximum infusion volume
of 600 mL per site (or as tolerated). If using three sites, the
maximum is 400 mL per site. Paediatric population: Replacement
therapy and Immunomodulatory therapy: follow adult dosage
guidance.
Contraindications:
Hypersensitivity to any ingredient or human IG especially in
patients with antibodies against IgA; systemic hypersensitivity to
hyaluronidase or human recombinant hyaluronidase; HyQvia must not
be given IV or intramuscularly.
Warnings and precautions: If
HyQvia is accidentally administered into a blood vessel, patients
could develop shock. The recommended infusion rate given in the
SmPC should be adhered to. Infuse slowly and monitor closely
throughout the infusion period, particularly patients starting
therapy. Patients may require monitoring for up to 1 hour after
administration. Manage infusion related events by slowing the
infusion rate or stopping the infusion. Treatment will depend on
the nature and severity of the adverse event. Patients should be
reminded to report chronic inflammation and nodules which occur at
the infusion site or other locations. For home treatment, patients
should have the support of another responsible person in case of
adverse reactions. Record treatment with HyQvia and batch number in
patients’ notes.
Hypersensitivity: Hypersensitivity
reactions are possible in patients with anti-IgA antibodies who
should only be treated with HyQvia if alternative treatments are
not possible and under close medical
supervision. In case of hypersensitivity, shock or
anaphylactic-like reactions, discontinue the infusion immediately
and treat the patient for shock. Rarely, human normal IG can induce
a fall in blood pressure with anaphylactic reaction. In high-risk
patients HyQvia should only be administered where supportive care
is available for life threatening reactions. Patients should be
informed of the early signs of anaphylaxis/ hypersensitivity.
Pre-medication may be used as a preventative measure.
Hypersensitivity to recombinant human
hyaluronidase: Any suspicion of allergic or anaphylactic
like reactions following recombinant human hyaluronidase
administration requires immediate discontinuation of the infusion
and standard medical treatment should be administered, if
necessary.
Immunogenicity of recombinant human
hyaluronidase: Development of non-neutralising antibodies
and neutralizing antibodies to the recombinant human hyaluronidase
component has been reported in patients receiving HyQvia in
clinical studies.
Thromboembolism: Thromboembolic
events including myocardial infarction, stroke, deep venous
thrombosis and pulmonary embolism have been observed with IG
treatment and cannot be excluded with use of HyQvia. Ensure
adequate hydration prior to treatment. Monitor for signs and
symptoms of thrombosis and assess blood viscosity in patients at
risk. Patients should be informed about initial symptoms and
advised to contact their physician immediately upon onset.
Haemolytic anaemia: IG products
contain antibodies to blood groups (e.g. A, B, D) which may act as
haemolysins. Monitor for signs and symptoms of haemolysis.
Aseptic meningitis syndrome: has
been reported, symptoms usually begin within several hours to 2
days following treatment. Patients should be informed about initial
symptoms. Discontinuation of IG treatment may result in remission
within several days without sequelae.
Interference with serological
testing: After infusion of immunoglobulins, the transitory
rise of the various passively transferred antibodies in the
patient’s blood may result in misleading positive results in
serological testing. Passive transmission of antibodies to
erythrocyte´s surface antigens may interfere with some serological
tests for red cell antibodies. Infusions of immunoglobulin products
may lead to false positive readings in assays that depend on
detection of β-D glucans for diagnosis of fungal infections.
Transmissible agents: Infectious
diseases due to the transmission of infective agents cannot be
totally excluded.
Sodium content: The recombinant
human hyaluronidase component contains 4.03 mg sodium/mL. To be
taken into consideration by patients on a controlled sodium
diet.
Traceability: The name and the
batch number of the administered product should be clearly
recorded.
Interactions: Live attenuated virus vaccines – postpone
vaccination for 3 months after treatment with HyQvia. For measles
vaccine, impairment may persist for up to 1 year, so check antibody
status. Please see the SmPC for details.
Fertility, pregnancy and
lactation: Safety during pregnancy has not been
established and immunoglobulins are excreted into the milk,
therefore use with caution in pregnant and breastfeeding
mothers.
Effects on ability to drive and use
machines: The ability to drive and operate machines may
be impaired by some adverse reactions e.g., dizziness associated
with this medicinal product. Patients who experience adverse
reactions during treatment should wait for these to resolve before
driving or operating machines.
Undesirable effects:
Very common (≥1/10 patients):
Headache, Blood pressure increased and Hypertension, Nauseam
Diarrhoea, Vomiting, Arthralgia, Local reactions (Infusion site
discomfort, Infusion site pain, Injection site pain, Puncture site
pain and Tenderness; infusion site erythema and Injection site
erythema; Infusion site oedema, Injection site oedema, infusion
site swelling, Injection site swelling and Swelling (local),
Feeling hot, Asthenia, Fatigue, Lethargy and Malaise.
Common (≥1/100, <1/10 patients):
Migraine, Tremor, Paraesthesia, Sinus tachycardia and Tachycardia,
Hypotension, Dyspnoea, Abdominal distension, Erythema, Pruritus,
Rash, Rash erythematous, Rash macular, Rash maculo-papular and Rash
popular Urticaria, Myalgia, Limb discomfort and Pain in extremity,
Back pain, Joint stiffness, Musculoskeletal chest pain, Groin pain,
Hemosiderinuria, Infusion related reaction, Infusion site bruising,
Injection site bruising, Infusion site haematoma, Injection site
haematoma, Infusion site haemorrhage and Vessel puncture site
bruise, Infusion site reaction, Injection site reaction and
Puncture site reaction, Infusion site mass, Injection site mass and
Infusion site nodule, Infusion site discoloration, Infusion site
rash and Injection site rash, Infusion site induration and
Injection site induration, Infusion site warmth, Infusion site
paraesthesia and Injection site paraesthesia, Infusion site
inflammation, Chills, Oedema, Oedema peripheral and Swelling
(systemic), Localised oedema, Peripheral swelling and Skin oedema,
Gravitational oedema, Oedema genital, Scrotal swelling and
Vulvovaginal swelling, Hyperhidrosis, Coombs direct test positive
and Coombs test positive.
Uncommon (≥ 1/1 000 to < 1/100):
Cerebrovascular accident and Ischaemic stroke, Burning
sensations.
Other undesirable effects (rare or unknown
frequency): Meningitis aseptic, Hypersensitivity, Direct
Coombs’ test positive, Infusion site leakage, Influenza-like
illness.
Refer to the SmPC for details on full side effect and
interactions.
Marketing Authorisation (MA)
numbers: 2.5g EU/1/13/840/001, 5g EU/1/13/840/002, 10g
EU/1/13/840/003, 20g EU/1/13/840/004, 30g EU/1/13/840/005.
Name and address of MA holder:
Baxalta Innovations GmbH, Industriestrasse 67, A-1221 Vienna,
Austria. HyQvia is a registered trade name.
PI approval code:
PI-02941
Date of preparation: January
2024.
Further information is available on request.
Adverse events should be reported to the authorities in your
country as required by local law. Adverse events should also be
reported to Takeda at: GPSE@takeda.com.
For Full U.S. Prescribing Information, please visit:
https://www.shirecontent.com/PI/PDFs/HYQVIA_USA_ENG.pdf
About Takeda
Takeda is focused on creating better health for people and a
brighter future for the world. We aim to discover and deliver
life-transforming treatments in our core therapeutic and business
areas, including gastrointestinal and inflammation, rare diseases,
plasma-derived therapies, oncology, neuroscience and vaccines.
Together with our partners, we aim to improve the patient
experience and advance a new frontier of treatment options through
our dynamic and diverse pipeline. As a leading values-based,
R&D-driven biopharmaceutical company headquartered in Japan, we
are guided by our commitment to patients, our people and the
planet. Our employees in approximately 80 countries and regions are
driven by our purpose and are grounded in the values that have
defined us for more than two centuries. For more information, visit
www.takeda.com.
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Medical Information
This press release contains information about products that may
not be available in all countries, or may be available under
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dosages, or in different strengths. Nothing contained herein should
be considered a solicitation, promotion or advertisement for any
prescription drugs including the ones under development.
_____________________________________ 1 Takeda Pharmaceuticals.
(2023 December 15). Takeda Receives Positive CHMP Opinion for
HYQVIA® as Maintenance Therapy in Patients with Chronic
Inflammatory Demyelinating Polyneuropathy (CIDP) [Press Release].
Available here. Last accessed January 2024. 2 Takeda
Pharmaceuticals. (2024 January 16). U.S. FDA Approves Takeda’s
HYQVIA® as Maintenance Therapy in Adults with Chronic Inflammatory
Demyelinating Polyneuropathy (CIDP) [Press Release]. Available
here. Last accessed January 2024. 3 European Medicines Agency.
HyQvia 100 mg/mL solution for infusion for subcutaneous use Summary
of Product Characteristics. Available at
https://www.ema.europa.eu/en/documents/product-information/hyqvia-epar-product-information_en.pdf.
4 Dalakas MC; Medscape. Advances in the diagnosis, pathogenesis and
treatment of CIDP. Nat Rev Neurol. 2011;7(9):507-517. 5 Eftimov F,
et al. Intravenous immunoglobulin for chronic inflammatory
demyelinating polyradiculoneuropathy. Cochrane Database Syst Rev.
2013;(12):CD001797. 6 Van den Bergh PYK, et al. European Academy of
Neurology/Peripheral Nerve Society guideline on diagnosis and
treatment of chronic inflammatory demyelinating
polyradiculoneuropathy: Report of a joint Task Force-Second
revision [published correction appears in J Peripher Nerv Syst.
2022 Mar;27(1):94]. 7 Bril V, et al. Hyaluronidase-facilitated
subcutaneous immunoglobulin 10% as maintenance therapy for chronic
inflammatory demyelinating polyradiculoneuropathy: The ADVANCE-CIDP
1 randomized controlled trial. J Peripher Nerv Syst.
2023;28(3):436-449. 8 European Medicines Agency. HyQvia product
information. Available here. Last Accessed January 2024
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Media Contacts: International Media Lauren Padovan
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