Grifols receives expanded XEMBIFY® (immune globulin subcutaneous human-klhw) label in U.S., strengthening its Ig portfolio for patients
Grifols (GRFS) has received FDA approval for an expanded label for XEMBIFY®, its 20% subcutaneous immunoglobulin (SCIg) treatment. The new label includes treatment-naïve patients with primary humoral immunodeficiencies (PI), making XEMBIFY the first and only 20% SCIg with this extended label. This allows patients to start SCIg therapy without initial intravenous administration.
The approval also includes biweekly dosing, supported by phase 4 clinical trial data showing non-inferiority in total Ig levels compared to weekly administration. The expanded label aims to provide greater flexibility and convenience for patients. Grifols plans to launch the new label in the U.S. in Q3 2024, aligning with its strategy to increase XEMBIFY adoption and strengthen its position in the growing Ig market for immunodeficiencies.
Grifols (GRFS) ha ricevuto l'approvazione della FDA per un'etichetta ampliata per XEMBIFY®, il suo trattamento di immunoglobulina subcutanea al 20% (SCIg). La nuova etichetta include pazienti naive al trattamento con immunodeficienze umorali primarie (PI), rendendo XEMBIFY il primo e unico SCIg al 20% con questa etichetta estesa. Questo consente ai pazienti di iniziare la terapia SCIg senza somministrazione endovenosa iniziale.
L'approvazione include inoltre dosaggi bisettimanali, supportati da dati di trial clinici di fase 4 che mostrano non inferiorità nei livelli totali di Ig rispetto alla somministrazione settimanale. L'etichetta ampliata mira a fornire maggiore flessibilità e convenienza per i pazienti. Grifols prevede di lanciare la nuova etichetta negli Stati Uniti nel Q3 2024, in linea con la sua strategia di aumentare l'adozione di XEMBIFY e rafforzare la sua posizione nel crescente mercato delle Ig per le immunodeficienze.
Grifols (GRFS) ha recibido la aprobación de la FDA para una etiqueta ampliada de XEMBIFY®, su tratamiento de inmunoglobulina subcutánea al 20% (SCIg). La nueva etiqueta incluye pacientes naïve al tratamiento con deficiencias inmunitarias humorales primarias (PI), lo que hace de XEMBIFY el primer y único SCIg al 20% con esta etiqueta extendida. Esto permite a los pacientes comenzar la terapia SCIg sin administración endovenosa inicial.
La aprobación también incluye dosis quincenales, respaldadas por datos de ensayos clínicos de fase 4 que muestran no inferioridad en los niveles totales de Ig en comparación con la administración semanal. La etiqueta ampliada busca proporcionar mayor flexibilidad y conveniencia para los pacientes. Grifols planea lanzar la nueva etiqueta en EE. UU. en el tercer trimestre de 2024, alineándose con su estrategia de aumentar la adopción de XEMBIFY y fortalecer su posición en el creciente mercado de Ig para deficiencias inmunitarias.
Grifols (GRFS)는 XEMBIFY®의 확장된 라벨에 대해 FDA 승인을 받았습니다. 이 제품은 20% 피하 면역글로불린(SCIg) 치료제입니다. 새로운 라벨은 치료 경험이 없는 환자들을 포함하며, 이는 XEMBIFY가 이러한 확장된 라벨을 가진 유일한 20% SCIg임을 의미합니다. 이를 통해 환자들은 초기 정맥 주사 없이 SCIg 요법을 시작할 수 있습니다.
승인된 내용에는 격주 투여도 포함되며, 이는 주간 투여 방식과 비교해 총 Ig 수치에서 비열등성을 보여주는 4상 임상 시험 데이터에 의해 뒷받침됩니다. 확장된 라벨은 환자들에게 더 큰 유연성 및 편의성을 제공하는 것을 목표로 하고 있습니다. Grifols는 2024년 3분기에 미국에서 새로운 라벨을 출시할 계획이며, 이는 XEMBIFY 채택을 늘리고 면역결핍증 시장에서의 입지를 강화하려는 전략과 일치합니다.
Grifols (GRFS) a reçu l'approbation de la FDA pour une étiquette élargie pour XEMBIFY®, son traitement d'immunoglobuline sous-cutanée à 20% (SCIg). La nouvelle étiquette inclut des patients naïfs au traitement souffrant d'immunodéficiences humorales primaires (PI), faisant de XEMBIFY le premier et seul SCIg à 20% avec cette étiquette étendue. Cela permet aux patients de commencer la thérapie SCIg sans administration intraveineuse initiale.
L'approbation comprend également une posologie bihebdomadaire, soutenue par des données d'essais cliniques de phase 4 montrant une non-infériorité des niveaux d'Ig totaux par rapport à une administration hebdomadaire. L'étiquette élargie vise à fournir plus de flexibilité et de commodité pour les patients. Grifols prévoit de lancer la nouvelle étiquette aux États-Unis au troisième trimestre 2024, conformément à sa stratégie d'augmenter l'adoption de XEMBIFY et de renforcer sa position sur le marché croissant des Ig pour les immunodéficiences.
Grifols (GRFS) hat die FDA-Zulassung für ein erweitertes Etikett von XEMBIFY®, seiner subkutanen Immunoglobulinbehandlung mit 20% (SCIg), erhalten. Das neue Etikett umfasst behandlungsnaive Patienten mit primären humoral-immunologischen Defiziten (PI), was XEMBIFY zum ersten und einzigen 20% SCIg mit diesem erweiterten Etikett macht. Dies ermöglicht es Patienten, die SCIg-Therapie ohne anfängliche intravenöse Verabreichung zu beginnen.
Die Genehmigung umfasst auch biwöchentliche Dosierungen, unterstützt durch Daten aus klinischen Studien der Phase 4, die zeigen, dass die Gesamt-Ig-Werte im Vergleich zur wöchentlichen Verabreichung nicht unterlegen sind. Das erweiterte Etikett zielt darauf ab, größere Flexibilität und Bequemlichkeit für die Patienten zu bieten. Grifols plant, das neue Etikett im dritten Quartal 2024 in den USA einzuführen, was im Einklang mit seiner Strategie steht, die Akzeptanz von XEMBIFY zu erhöhen und seine Position auf dem wachsenden Ig-Markt für Immundefizite zu stärken.
- FDA approval for expanded XEMBIFY label, including treatment-naïve patients and biweekly dosing
- XEMBIFY becomes the first 20% SCIg with extended label for treatment-naïve patients
- Phase 4 clinical trial data supports efficacy and safety of biweekly dosing
- Expanded label provides greater flexibility and convenience for patients
- Aligns with Grifols' strategy to increase XEMBIFY adoption in the growing Ig market
- None.
The FDA's expanded label approval for XEMBIFY® marks a significant advancement in immunoglobulin therapy. As the first 20% subcutaneous immunoglobulin (SCIg) approved for treatment-naïve patients, it eliminates the need for initial intravenous administration. This could potentially improve patient comfort and adherence to treatment regimens.
The approval of biweekly dosing, supported by phase 4 clinical trial data, demonstrates comparable efficacy to weekly dosing. This flexibility could enhance patient quality of life by reducing the frequency of treatments. The study's results, showing non-inferiority in total Ig levels and consistent tolerability profiles, provide robust evidence for the safety and efficacy of this new dosing schedule.
From a market perspective, this expanded label positions XEMBIFY® favorably in the growing immunoglobulin market. With immunodeficiencies representing up to
Grifols' strategic focus on expanding its immunoglobulin (Ig) portfolio, particularly with XEMBIFY®'s label expansion, aligns well with projected market trends. The global Ig market is expected to grow at high single-digit rates in the coming years, primarily driven by increased demand for primary and secondary immunodeficiency treatments.
This label expansion could potentially accelerate XEMBIFY®'s market penetration by offering unique benefits to treatment-naïve patients and those preferring less frequent dosing. The elimination of initial intravenous therapy and the option for biweekly dosing may give XEMBIFY® a competitive edge in the SCIg market.
Financially, this could translate to increased revenue streams for Grifols in the medium to long term. The company's focus on immunodeficiencies, which represent over half of the total Ig market, positions it well to capture a significant share of this growing segment. However, investors should note that the impact on financials may not be immediate, as the new label launch is planned for Q3 2024.
The expansion into European markets and ongoing efforts to launch XEMBIFY® in additional countries further support Grifols' growth strategy in the Ig segment. This geographical diversification could help mitigate market-specific risks and provide multiple avenues for revenue growth.
The expanded label for XEMBIFY® represents a strategic market positioning move by Grifols. By becoming the first and only 20% SCIg with FDA approval for treatment-naïve patients, Grifols has created a unique selling proposition in a competitive market. This differentiation could lead to increased market share and potentially higher pricing power.
The inclusion of biweekly dosing aligns with the growing trend of patient-centric healthcare solutions. This flexibility in treatment schedules could be a significant factor in patient choice, potentially driving preference for XEMBIFY® over competitors. The convenience factor could also lead to improved patient adherence, which is important for long-term treatment success and could positively influence healthcare provider recommendations.
Grifols' focus on immunodeficiencies, which account for more than half of the total Ig market, demonstrates a keen understanding of market dynamics. With this segment expected to outpace growth in other indications, Grifols is positioning itself to capture a larger share of the fastest-growing part of the Ig market.
The planned launch in Q3 2024 gives Grifols time to prepare its marketing strategy and educate healthcare providers about the new label. This timing could coincide with the potential post-pandemic normalization of healthcare services, possibly leading to increased diagnosis rates of primary immunodeficiencies and subsequently higher demand for treatments like XEMBIFY®.
- XEMBIFY is the first and only
20% subcutaneous immunoglobulin (SCIg) with FDA-approved dosing for treatment-naïve patients, enabling them to go straight to SCIg without initial intravenous therapy
- Approval, which also includes biweekly dosing, follows phase 4 study data demonstrating comparable total Ig levels when administering XEMBIFY every two weeks versus weekly
- The expanded label for XEMBIFY provides added flexibility and convenience for patients with primary humoral immunodeficiencies
- Increasing adoption of XEMBIFY is part of Grifols’ broader Ig business strategy focused on treating immunodeficiencies, which represent more than half of the total Ig market and whose growth is expected to outpace other indications
BARCELONA, Spain, July 29, 2024 (GLOBE NEWSWIRE) -- Grifols (MCE: GRF, MCE: GRF.P NASDAQ: GRFS), one of the world’s leading producers of plasma-derived medicines, today announced that the United States Food and Drug Administration (FDA) has approved an expanded label for XEMBIFY®, the company’s
XEMBIFY becomes the first
FDA approval of the Supplemental Biologics Application (sBLA) also includes biweekly dosing and is supported by phase 4 clinical trial (NCT04566692) data shared last year. XEMBIFY met its primary endpoint, demonstrating that patients with PI treated with XEMBIFY every two weeks achieved non-inferiority in total Ig levels compared with those who received the medication every seven days.
There were no unique safety issues identified in the trial and the tolerability profiles were consistent between biweekly and weekly administration. The phase 4 trial was a multicenter, single-sequence, open-label study that included 27 subjects across 18 U.S. sites.
Greater adoption of XEMBIFY forms part of Grifols’ wider Ig business strategy. The global market for Ig is expected to grow in the high single digits in the coming years as a result of the increase in PI and secondary immunodeficiencies (SID), which together account for up to
“The XEMBIFY label expansion eliminates the need for patients to have initial intravenous treatment, which differentiates XEMBIFY from other SCIg therapies, plus offers patients greater convenience and flexibility with biweekly dosing,” said Joerg Schuettrumpf, Grifols Chief Scientific Innovation Officer. “Grifols plans to launch the new label in the U.S. in the third quarter of 2024 as part of the company’s commitment to increasing options for patients and adapting to their needs and lifestyles.”
The biweekly dosing option is already available in the European markets where XEMBIFY is commercialized, including Czech Republic, France, Iceland, Norway, Slovakia, Spain and Sweden. The company is also working on launching XEMBIFY in other European countries.
XEMBIFY is indicated for PI in the U.S. and both PI and select SID in Europe, Canada and Australia.
About XEMBIFY®
Grifols XEMBIFY® is a
INDICATION
XEMBIFY® (immune globulin subcutaneous, human–klhw) is a
IMPORTANT SAFETY INFORMATION
WARNING: THROMBOSIS
- Thrombosis may occur with immune globulin products, including XEMBIFY®. Risk factors may include: advanced age, prolonged immobilization, estrogens, indwelling vascular catheters, hyperviscosity, and cardiovascular risk factors. Thrombosis may occur in the absence of known risk factors
- For patients at risk of thrombosis, administer XEMBIFY® 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 of hyperviscosity
Contraindications
XEMBIFY® is contraindicated in patients who have had an anaphylactic or severe systemic reaction to the administration of human immune globulin. It is contraindicated in IgA-deficient patients with antibodies against IgA and a history of hypersensitivity.
Warnings and Precautions
Aseptic meningitis syndrome (AMS). AMS may occur with human immune globulin treatment, including XEMBIFY®. Conduct a thorough neurological exam on patients exhibiting signs and symptoms to rule out other causes of meningitis. Discontinuation of treatment has resulted in remission within several days without sequelae.
Thrombosis. Thrombosis may occur following treatment with immune globulin products, including XEMBIFY®. Thrombosis may occur in the absence of known risk factors. In patients at risk, administer at the minimum dose and infusion rate practicable. Ensure adequate hydration before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk of hyperviscosity.
Hypersensitivity. Severe hypersensitivity reactions may occur with immune globulin products, including XEMBIFY®. In case of hypersensitivity, discontinue infusion immediately and institute appropriate treatment. XEMBIFY contains IgA. Patients with known antibodies to IgA may have a greater risk of developing potentially severe hypersensitivity and anaphylactic reactions.
Renal dysfunction/failure. Acute renal dysfunction/failure, acute tubular necrosis, proximal tubular nephropathy, osmotic nephrosis, and death may occur with use of human immune globulin products, especially those containing sucrose. XEMBIFY® does not contain sucrose. Ensure patients are not volume-depleted prior to starting infusion. In patients at risk due to preexisting renal insufficiency or predisposition to acute renal failure, assess renal function prior to the initial infusion of XEMBIFY® and again at appropriate intervals thereafter. If renal function deteriorates, consider discontinuation.
Hemolysis. XEMBIFY® may contain blood group antibodies that may cause a positive direct antiglobulin reaction and hemolysis. Monitor patients for clinical signs and symptoms of hemolysis. If signs and symptoms are present after infusion, perform confirmatory lab testing.
Transfusion-related acute lung injury (TRALI). Noncardiogenic pulmonary edema may occur in patients following treatment with immune globulin products, including XEMBIFY®. Monitor patients for pulmonary adverse reactions. If TRALI is suspected, perform appropriate tests for the presence of antineutrophil and anti-HLA antibodies in both the product and patient serum. TRALI may be managed using oxygen therapy with adequate ventilatory support.
Transmissible infectious agents. Because XEMBIFY® 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. No cases of transmission of viral diseases, vCJD, or CJD have ever been associated with the use of XEMBIFY®.
Interference with lab tests. After infusion of XEMBIFY®, passively transferred antibodies in the patient’s blood may yield positive serological testing results, with the potential for misleading interpretation.
Adverse Reactions
The most common adverse reactions in ≥
Drug Interactions
Passive transfer of antibodies may transiently interfere with the immune responses to live attenuated virus vaccines (eg, measles, mumps, rubella, and varicella).
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Please see full Prescribing Information for XEMBIFY® or visit www.xembify.com
Globally, prescribing information varies; refer to the individual country product label for complete information.
About Grifols
Grifols is a global healthcare company founded in Barcelona in 1909 committed to improving the health and well-being of people around the world. A leader in essential plasma-derived medicines and transfusion medicine, the company develops, produces and provides innovative healthcare services and solutions in more than 110 countries.
Patient needs and Grifols’ ever-growing knowledge of many chronic, rare and prevalent conditions, at times life-threatening, drive the company’s innovation in both plasma and other biopharmaceuticals. The company is focused on treating conditions across a broad range of therapeutic areas: immunology, hepatology and intensive care, pulmonology, hematology, neurology and infectious diseases.
A pioneer in the plasma industry, Grifols continues to grow its network of donation centers, the world’s largest with over 390 across North America, Europe, Africa and the Middle East and China.
As a recognized leader in transfusion medicine, Grifols offers a comprehensive portfolio of solutions designed to enhance safety from donation to transfusion, in addition to clinical diagnostic technologies. It provides high-quality biological supplies for life-science research, clinical trials, and for manufacturing pharmaceutical and diagnostic products. The company also supplies tools, information and services that enable hospitals, pharmacies and healthcare professionals to efficiently deliver expert medical care.
Grifols, with more than 24,000 employees in more than 30 countries and regions, is committed to a sustainable business model that sets the standard for continuous innovation, quality, safety and ethical leadership.
The company’s class A shares are listed on the Spanish Stock Exchange, where they are part of the Ibex-35 (MCE:GRF). Grifols non-voting class B shares are listed on the Mercado Continuo (MCE:GRF.P) and on the U.S. NASDAQ through ADRs (NASDAQ:GRFS).
For more information, please visit www.grifols.com
MEDIA CONTACT:
Media Press Office
media@grifols.com
Tel. +34 93 571 00 02
INVESTORS:
Investors Relations Department & Sustainability
inversores@grifols.com - investors@grifols.com
Tel. +34 93 571 02 21
LEGAL DISCLAIMER
The facts and figures contained in this report that do not refer to historical data are “future projections and assumptions”. Words and expressions such as “believe”, “hope”, “anticipate”, “predict”, “expect”, “intend”, “should”, “will seek to achieve”, “it is estimated”, “future” and similar expressions, insofar as they relate to the Grifols group, are used to identify future projections and assumptions. These expressions reflect the assumptions, hypotheses, expectations and predictions of the management team at the time of writing this report, and these are subject to a number of factors that mean that the actual results may be materially different. The future results of the Grifols group could be affected by events relating to its own activities, such as a shortage of supplies of raw materials for the manufacture of its products, the appearance of competitor products on the market, or changes to the regulatory framework of the markets in which it operates, among others. At the date of compiling this report, the Grifols group has adopted the necessary measures to mitigate the potential impact of these events. Grifols, S.A. does not accept any obligation to publicly report, revise or update future projections or assumptions to adapt them to events or circumstances subsequent to the date of writing this report, except where expressly required by the applicable legislation. This document does not constitute an offer or invitation to buy or subscribe shares in accordance with the provisions of the following Spanish legislation: Royal Legislative Decree 4/2015, of 23 October, approving recast text of Securities Market Law; Royal Decree Law 5/2005, of 11 March and/or Royal Decree 1310/2005, of 4 November, and any regulations developing this legislation. In addition, this document does not constitute an offer of purchase, sale or exchange, or a request for an offer of purchase, sale or exchange of securities, or a request for any vote or approval in any other jurisdiction. The information included in this document has not been verified nor reviewed by the external auditors of the Grifols group.
© 2024 Grifols All Rights Reserved July 2024 US-XEM-2400176
1 Marketing Research Bureau. Global Usage and Forecast of the Immunoglobulin Market by Region
FAQ
What new FDA approval did Grifols (GRFS) receive for XEMBIFY?
How does the new XEMBIFY label benefit patients according to Grifols (GRFS)?
When does Grifols (GRFS) plan to launch the new XEMBIFY label in the U.S.?
What clinical data supports the expanded XEMBIFY label for Grifols (GRFS)?
