- One trial, SIGMA, will review Grifols’ intravenous immunoglobulin (Ig) GAMUNEX®-C (immune globulin injection [human], 10% caprylate chromatography purified) plus usual scientific remedy in sufferers with secondary immunodeficiency
- A 2d trial, XPERT, will decide whether or not Grifols’ subcutaneous Ig, XEMBIFY® (immune globulin subcutaneous human klhw) is non-inferior to GAMUNEX-C in sufferers with Persistent Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
- Each research are designed to reinforce U.S. label growth on those fast-growing Grifols Ig franchise remedies and be offering sufferers extra remedy choices for his or her immune formula problems
BARCELONA, Spain — Grifols, an international healthcare corporate and main manufacturer of plasma-derived drugs, as of late introduced that the primary sufferers were dosed in two separate Segment 3 trials aiming to amplify the U.S. labels for its signature immunoglobulin therapeutics, GAMUNEX®-C, an intravenous immunoglobulin (IVIg), and XEMBIFY®, its subcutaneous immunoglobulin (SCIg).
The SIGMA trial (NCT07582432) will review the pharmacokinetics (PK), efficacy and protection of GAMUNEX-C together with usual of care remedy to stop infections in sufferers with secondary immunodeficiency (SID) characterised via low immunoglobulin ranges. Not like number one immunodeficiency (PID), which is genetic, SID happens when an individual’s prior to now wholesome immune formula is compromised via components comparable to blood most cancers and coverings like chemotherapy or B-cell-targeted remedies.
This trial will center of attention in particular on sufferers with commonplace blood cancers together with Persistent Lymphocytic Leukemia (CLL), A couple of Myeloma (MM) and Non-Hodgkin Lymphoma (NHL), which in combination account for greater than 1 million sufferers within the U.S.1 Increasing the label to incorporate hematologic most cancers–related SID would expand the licensed indications for GAMUNEX-C within the U.S.
The second one scientific trial, XPERT (NCT07540221) will decide if XEMBIFY’s PK profile is non-inferior to that of GAMUNEX-C to regard sufferers with Persistent Inflammatory Demyelinating Polyradiculoneuropathy (CIDP). It is going to additionally review XEMBIFY’s protection profile and efficacy in keeping with its talent to stay the sufferers’ situation below keep watch over. GAMUNEX-C is already indicated to regard this autoimmune illness. Favorable effects appearing non-inferiority between the 2 Ig therapeutics, which percentage equivalent production processes, would possibly reinforce long run regulatory discussions, together with a possible software to hunt growth of XEMBIFY’s U.S. label to incorporate CIDP.
About 60,000 sufferers within the U.S.2 be afflicted by CIDP, a prolonged sickness, with signs together with innovative weak spot within the legs and arms and adjustments in sensation. Ig remedy, together with GAMUNEX-C, is a first-line remedy with immunomodulatory houses that may reinforce neuromuscular incapacity and save you relapse.
“The GBS I CIDP Foundation International embraces Grifols’ commitment to innovate and to support the patient community with additional choice in treatment and access options,” mentioned Lisa Butler, president and CEO of The GBS | CIDP Basis, which matches to make sure the CIDP affected person group has get right of entry to to all vital remedies in any respect issues of care.
Those two new trials purpose to amplify the U.S. indications of Grifols’ Ig portfolio, including to a 3rd Ig trial already underway. Introduced on the finish of 2022, Grifols’ EXCELL trial (NCT05645107) is a learn to guage efficacy, protection, and PK of XEMBIFY+usual scientific remedy (SMT) in comparison to placebo+SMT to stop infections in members with hypogammaglobulinemia (HGG) and recurrent or serious infections related to B-cell Persistent Lymphocytic Leukemia, A couple of Myeloma, and Non-Hodgkin Lymphoma.
“We’re excited about the potential to provide patients with more immunoglobulin treatment options to help manage their conditions with flexibility and convenience,” mentioned Eduardo Herrero, Grifols’ Govt Vice President Biopharma Business and Clinical Innovation. “Whether it’s our IVIg or SCIg treatments, Grifols’ Igs are backed by decades of deep expertise on this protein.”
Grifols’ suite of Ig merchandise to regard immune-system problems continues to accomplish very strongly, pushed via expanding affected person want the world over. XEMBIFY, specifically, has benefited from tough call for, rising just about 60% yr over yr in 2025.
Concerning the new Segment 3 trials
The main efficacy function of the SIGMA trial is to exhibit that the speed of great bacterial infections is not up to 1 in step with player in step with yr when handled with GAMUNEX-C plus usual of care scientific remedy. Fifty members will participate within the open-label, multicenter single-arm potential learn, all recognized with B-cell CLL, MM or NHL with hypogammaglobulinemia.
The XPERT trial is an open-label, multicenter learn that may review the PK, efficacy and protection of XEMBIFY in comparison to GAMUNEX-C as upkeep remedy in roughly 40 CIDP sufferers throughout 20 websites within the U.S. and Europe.
This trial builds at the corporate’s longstanding historical past of making an investment in CIDP analysis and remedy choices for this affected person group. Within the mid-2000s, a pivotal trial focused on Gamunex-C –– demonstrated its momentary and long-term efficacy in lowering incapacity, together with growth in grip energy, in sufferers with CIDP in comparison to placebo.
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1 Nationwide Most cancers Institute. SEER Most cancers Stat Information. Surveillance, Epidemiology, and Finish Effects Program. Up to date April 15, 2022. Accessed July 14, 2025.
2 Arackal S, Venker C, Wang M, Schwinn J, Mina-Osorio P. Assessing the occurrence and incidence of continual inflammatory demyelinating polyradiculoneuropathy in america: retrospective claims information research. Neurology. 2024;102(7 Suppl 1):P9-11.010. Printed April 9, 2024. doi:10.1212/WNL.0000000000204780
About GAMUNEX®-C within the U.S.
Indication
GAMUNEX-C (immune globulin injection [human], 10% caprylate/chromatography purified) is indicated for the remedy of number one humoral immunodeficiency illness (PIDD) in sufferers 2 years of age and older, idiopathic thrombocytopenic purpura (ITP) in adults and youngsters, and persistent inflammatory demyelinating polyneuropathy (CIDP) in adults.
Necessary Protection Data
Thrombosis would possibly happen with immune globulin merchandise, together with GAMUNEX-C. Possibility components would possibly come with: complex age, extended immobilization, hypercoagulable stipulations, historical past of venous or arterial thrombosis, use of estrogens, indwelling central vascular catheters, hyperviscosity, and cardiovascular possibility components. Thrombosis would possibly happen within the absence of identified possibility components. For sufferers vulnerable to thrombosis, administer GAMUNEX-C on the minimal dose and infusion charge practicable. Ensure that good enough hydration in sufferers ahead of management. Observe for indicators and signs of thrombosis and assess blood viscosity in sufferers in peril for hyperviscosity.
Renal disorder, acute renal failure, osmotic nephrosis, and demise would possibly happen with immune globulin intravenous (IVIG) merchandise in predisposed sufferers. Sufferers predisposed to renal disorder come with the ones with any level of preexisting renal insufficiency, diabetes mellitus, age more than 65, quantity depletion, sepsis, paraproteinemia, or sufferers receiving identified nephrotoxic medicine. Renal disorder and acute renal failure happen extra recurrently in sufferers receiving IVIG merchandise containing sucrose. GAMUNEX-C does no longer include sucrose. For sufferers vulnerable to renal disorder or failure, administer GAMUNEX-C on the minimal focus to be had and the minimal infusion charge practicable.
GAMUNEX-C is contraindicated in sufferers who’ve had an anaphylactic or serious systemic response to the management of human immune globulin. It’s contraindicated in IgA-deficient sufferers with antibodies towards IgA and historical past of allergy.
Serious allergy reactions would possibly happen with IVIG merchandise, together with GAMUNEX-C. In case of allergy, discontinue GAMUNEX-C infusion right away and institute suitable remedy.
Observe renal serve as, together with blood urea nitrogen (BUN), serum creatinine, and urine output in sufferers vulnerable to growing acute renal failure.
Hyperproteinemia, larger serum viscosity, and hyponatremia would possibly happen in sufferers receiving IVIG remedy, together with GAMUNEX-C.
There were reviews of aseptic meningitis, hemolytic anemia, and noncardiogenic pulmonary edema (transfusion-related acute lung harm [TRALI]) in sufferers administered with IVIG, together with GAMUNEX-C.
The high-dose routine (1g/kg x 1-2 days) isn’t really helpful for people with expanded fluid volumes or the place fluid quantity is also a priority.
As a result of GAMUNEX-C is comprised of human blood, it’ll elevate a possibility of transmitting infectious brokers, eg, viruses, the variant Creutzfeldt-Jakob illness (vCJD) agent, and, theoretically, the Creutzfeldt-Jakob illness (CJD) agent.
Don’t administer GAMUNEX-C subcutaneously in sufferers with ITP as a result of the chance of hematoma formation.
Periodic tracking of renal serve as and urine output is especially vital in sufferers judged to be at larger possibility of growing acute renal failure. Assess renal serve as, together with dimension of BUN and serum creatinine, ahead of the preliminary infusion of GAMUNEX-C and at suitable durations thereafter.
Imagine baseline overview of blood viscosity in sufferers in peril for hyperviscosity, together with the ones with cryoglobulins, fasting chylomicronemia/markedly excessive triacylglycerols (triglycerides), or monoclonal gammopathies, as a result of the doubtless larger possibility of thrombosis.
If indicators and/or signs of hemolysis are provide after an infusion of GAMUNEX-C, carry out suitable laboratory checking out for affirmation.
If TRALI is suspected, carry out suitable checks for the presence of antineutrophil antibodies and anti-HLA antibodies in each the product and affected person’s serum.
After infusion of IgG, the transitory upward push of the more than a few passively transferred antibodies within the affected person’s blood would possibly yield sure serological checking out effects, with the potential of deceptive interpretation.
In scientific research, the most typical adversarial reactions with GAMUNEX-C had been headache, pyrexia, high blood pressure, chills, rash, nausea, arthralgia, and asthenia (in CIDP); cough, rhinitis, pharyngitis, headache, bronchial asthma, nausea, fever, diarrhea, and sinusitis with intravenous use (in PIDD) and native infusion-site reactions, fatigue, headache, higher breathing tract an infection, arthralgia, diarrhea, nausea, sinusitis, bronchitis, despair, allergic dermatitis, migraine, myalgia, viral an infection, and pyrexia with subcutaneous use (in PIDD); and headache, ecchymosis, vomiting, fever, nausea, rash, stomach ache, again ache, and dyspepsia (in ITP).
Essentially the most critical adversarial reactions in scientific research had been pulmonary embolism (PE) in 1 matter with a historical past of PE (in CIDP), an exacerbation of autoimmune natural purple mobile aplasia in 1 matter (in PIDD), and myocarditis in 1 matter that took place 50 days post-study drug infusion and used to be no longer thought to be drug-related (in ITP).
Please see complete Prescribing Data for GAMUNEX-C or discuss with www.gamunex-c.com.
About XEMBIFY® within the U.S.
Indication
XEMBIFY® (immune globulin subcutaneous human–klhw) is a 20% immune globulin indicated for remedy of number one humoral immunodeficiency illness (PIDD) in sufferers 2 years of age and older. XEMBIFY is for subcutaneous management handiest.
Necessary Protection Data WARNING: THROMBOSIS
- Thrombosis would possibly happen with immune globulin merchandise, together with XEMBIFY. Possibility components would possibly come with: complex age, extended immobilization, hypercoagulable stipulations, historical past of venous or arterial thrombosis, use of estrogens, indwelling vascular catheters, hyperviscosity, and cardiovascular possibility components. Thrombosis would possibly happen within the absence of identified possibility components
- For sufferers vulnerable to thrombosis, administer XEMBIFY on the minimal dose and infusion charge practicable. Ensure that good enough hydration in sufferers ahead of management. Observe for indicators and signs of thrombosis and assess blood viscosity in sufferers vulnerable to hyperviscosity
Contraindications
XEMBIFY is contraindicated in sufferers who’ve had an anaphylactic or serious systemic response to the management of human immune globulin. It’s contraindicated in IgA-deficient sufferers with antibodies towards IgA and a historical past of allergy.
Warnings and Precautions
Aseptic meningitis syndrome (AMS). AMS would possibly happen with human immune globulin remedy, together with XEMBIFY. Behavior an intensive neurological examination on sufferers showing indicators and signs to rule out different reasons of meningitis. Discontinuation of remedy has ended in remission inside of a number of days with out sequelae.
Thrombosis. Thrombosis would possibly happen following remedy with immune globulin merchandise, together with XEMBIFY. Thrombosis would possibly happen within the absence of identified possibility components. In sufferers in peril, administer on the minimal dose and infusion charge practicable. Ensure that good enough hydration ahead of management. Observe for indicators and signs of thrombosis and assess blood viscosity in sufferers vulnerable to hyperviscosity.
Allergy. Serious allergy reactions would possibly happen with immune globulin merchandise, together with XEMBIFY. In case of allergy, discontinue infusion right away and institute suitable remedy. XEMBIFY comprises IgA. Sufferers with identified antibodies to IgA can have a better possibility of growing probably serious allergy and anaphylactic reactions.
Renal disorder/failure. Acute renal disorder/failure, acute tubular necrosis, proximal tubular nephropathy, osmotic nephrosis, and demise would possibly happen with use of human immune globulin merchandise, particularly the ones containing sucrose. XEMBIFY does no longer include sucrose. Ensure that sufferers aren’t volume-depleted previous to beginning infusion. In sufferers in peril because of preexisting renal insufficiency or predisposition to acute renal failure, assess renal serve as previous to the preliminary infusion of XEMBIFY and once more at suitable durations thereafter. If renal serve as deteriorates, believe discontinuation.
Hemolysis. XEMBIFY would possibly include blood team antibodies that can purpose a favorable direct antiglobulin response and hemolysis. Observe sufferers for scientific indicators and signs of hemolysis. If indicators and signs are provide after infusion, carry out confirmatory lab checking out.
Transfusion-related acute lung harm (TRALI). Noncardiogenic pulmonary edema would possibly happen in sufferers following remedy with immune globulin merchandise, together with XEMBIFY. Observe sufferers for pulmonary adversarial reactions. If TRALI is suspected, carry out suitable checks for the presence of antineutrophil and anti-HLA antibodies in each the product and affected person serum. TRALI is also controlled the use of oxygen remedy with good enough ventilatory reinforce.
Transmissible infectious brokers. As a result of XEMBIFY is comprised of human blood, it’ll elevate a possibility of transmitting infectious brokers, eg, viruses, the variant Creutzfeldt- Jakob illness (vCJD) agent, and, theoretically, the Creutzfeldt-Jakob illness (CJD) agent. No circumstances of transmission of viral illnesses, vCJD, or CJD have ever been related to using XEMBIFY.
Interference with lab checks. After infusion of XEMBIFY, passively transferred antibodies within the affected person’s blood would possibly yield sure serological checking out effects, with the potential of deceptive interpretation.
Opposed Reactions
The commonest adversarial reactions in ≥ 5% of topics within the scientific trial had been native adversarial reactions, together with infusion-site erythema (redness), infusion-site ache, infusion-site swelling (puffiness), infusion-site bruising, infusion-site nodule, infusion-site pruritus (itching), infusion-site induration (firmness), infusion-site scab, infusion-site edema, and systemic reactions together with cough and diarrhea.
Drug Interactions
Passive switch of antibodies would possibly transiently intrude with the immune responses to are living attenuated virus vaccines (eg, measles, mumps, rubella, and varicella).
Please see accompanying complete Prescribing Data for XEMBIFY or discuss with www.xembify.com
Globally, prescribing data varies; confer with the person nation product label for entire data.
About Grifols
Grifols is an international healthcare corporate based in Barcelona in 1909 dedicated to bettering the well being and well-being of other people all over the world. A pace-setter in very important plasma-derived drugs and transfusion medication, the corporate develops, produces and gives leading edge healthcare products and services and answers in additional than 110 nations.
Affected person wishes and Grifols’ ever-growing wisdom of many continual, uncommon and prevalent stipulations, from time to time life-threatening, pressure the corporate’s innovation in each plasma and different biopharmaceuticals to strengthen high quality of lifestyles. Grifols specializes in treating stipulations focused on six core healing spaces: immunology, neurology, pulmonology, hematology, hepatology and extensive care.
A pioneer within the plasma trade, Grifols continues to develop its community of donation facilities, the arena’s maximum different with greater than 400 throughout North The usa, Europe, Africa and the Heart East, and China.
As a known chief in transfusion medication, Grifols gives a complete portfolio of answers designed to strengthen protection from donation to transfusion, along with scientific diagnostic applied sciences. It supplies top quality organic provides for life-science analysis, scientific trials and for production pharmaceutical and diagnostic merchandise. The corporate additionally provides gear, data and products and services that allow hospitals, pharmacies and healthcare execs to successfully ship skilled hospital treatment.
Grifols, with greater than 25,000 staff in additional than 30 nations and areas, is dedicated to a sustainable trade type that units the usual for steady innovation, high quality, protection and moral management.
The corporate’s elegance A stocks are indexed at the Spanish Inventory Alternate, the place they’re a part of the IBEX-35 (MCE:GRF). Grifols non- vote casting elegance B stocks are indexed at the Mercado Continuo (MCE:GRF.P) and at the U.S. NASDAQ via ADRs.
For more info about Grifols, please discuss with www.grifols.com.
MEDIA CONTACTS:
Grifols Press Place of job
media@grifols.com
Telephone: +34 93 571 00 02
INVESTORS:
Investor Family members & Sustainability
traders@grifols.com – inversores@grifols.com
sustainability@grifols.com – sostenibilidad@grifols.com
Telephone: +34 93 571 02 21
LEGAL DISCLAIMER
The information and figures contained on this file that don’t confer with historic information are ‘projections and future hypotheses’. Phrases and expressions comparable to ‘believe’, ‘expect’, ‘anticipate’, ‘predict’, ‘hope’, ‘intend’, ‘should’, ‘will try to achieve’, ‘is estimated’, ‘future’ and equivalent expressions, insofar as they confer with the Grifols team, are used to spot long run projections and hypotheses. Those expressions replicate the assumptions, hypotheses, expectancies and predictions of the control crew on the time of penning this file, and those are matter to a chain of things that imply that the actual effects is also materially other. The longer term result of the Grifols team may well be suffering from occasions associated with its personal actions, comparable to shortages of provides of uncooked fabrics for the manufacture of its merchandise, the illusion available on the market of competing merchandise, or adjustments within the regulatory framework of the markets during which it operates, amongst others. On the date of preparation of this file, the Grifols team has followed the vital measures to mitigate the foreseeable have an effect on of those occasions. Grifols, S.A. assumes no legal responsibility to publicly file, revise or replace the projections or long run hypotheses to conform them to information or instances after the date of writing of this file, with the exception of when expressly required via acceptable regulation. This file does no longer represent an be offering or invitation to buy or subscribe stocks in response to the provisions of Regulation 6/2023, of 17 March, at the Securities Markets and Funding Services and products, and any rules imposing mentioned regulation. Moreover, this file does no longer represent an be offering to buy, promote or change, or a solicitation of an be offering to buy, promote or change any securities, or a solicitation of any vote or approval in some other jurisdiction. The tips contained on this file has no longer been verified or revised via the exterior auditors of the Grifols team.
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