Halozyme Announces argenx Received Positive CHMP Opinion for VYVGART® (efgartigimod alfa) Subcutaneous Injection with ENHANZE® for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Halozyme Therapeutics (NASDAQ: HALO) announced that argenx received a positive CHMP opinion recommending European Commission approval for VYVGART® with ENHANZE® for chronic inflammatory demyelinating polyneuropathy (CIDP) treatment. The subcutaneous injection, available as a vial or prefilled syringe, is designed for adult patients with progressive or relapsing active CIDP after prior treatment with corticosteroids or immunoglobulins.
VYVGART represents the first targeted IgG Fc-antibody fragment for CIDP and the first novel mechanism of action in over 30 years. The recommendation is based on the ADHERE clinical trial, the largest CIDP patient study to date. The European Commission's decision, expected within two months, will apply to all 27 EU Member States plus Iceland, Norway, and Liechtenstein.
Halozyme Therapeutics (NASDAQ: HALO) ha annunciato che argenx ha ricevuto un parere positivo dal CHMP che raccomanda l'approvazione da parte della Commissione Europea per VYVGART® con ENHANZE® nel trattamento della polineuropatia infiammatoria demielinizzante cronica (CIDP). L'iniezione sottocutanea, disponibile in flaconcino o siringa pre-riempita, è destinata ai pazienti adulti con CIDP attiva progressiva o recidivante, dopo un trattamento precedente con corticosteroidi o immunoglobuline.
VYVGART rappresenta il primo frammento di anticorpo IgG Fc mirato per la CIDP e il primo nuovo meccanismo d'azione in oltre 30 anni. La raccomandazione si basa sullo studio clinico ADHERE, il più ampio studio su pazienti con CIDP fino ad oggi. La decisione della Commissione Europea, attesa entro due mesi, sarà valida per tutti i 27 Stati membri dell'UE oltre a Islanda, Norvegia e Liechtenstein.
Halozyme Therapeutics (NASDAQ: HALO) anunció que argenx recibió una opinión positiva del CHMP que recomienda la aprobación por parte de la Comisión Europea de VYVGART® con ENHANZE® para el tratamiento de la polineuropatía inflamatoria desmielinizante crónica (CIDP). La inyección subcutánea, disponible en vial o jeringa precargada, está diseñada para pacientes adultos con CIDP activa progresiva o recurrente tras un tratamiento previo con corticosteroides o inmunoglobulinas.
VYVGART representa el primer fragmento de anticuerpo Fc de IgG dirigido para CIDP y el primer nuevo mecanismo de acción en más de 30 años. La recomendación se basa en el ensayo clínico ADHERE, el estudio más grande realizado hasta la fecha en pacientes con CIDP. La decisión de la Comisión Europea, esperada en dos meses, se aplicará a los 27 Estados miembros de la UE más Islandia, Noruega y Liechtenstein.
Halozyme Therapeutics (NASDAQ: HALO)는 argenx가 만성 염증성 탈수초성 다발신경병증(CIDP) 치료를 위한 VYVGART® with ENHANZE®의 유럽 집행위원회 승인을 권고하는 CHMP 긍정적 의견을 받았다고 발표했습니다. 바이알 또는 프리필드 주사기로 제공되는 이 피하 주사는 코르티코스테로이드 또는 면역글로불린 치료를 받은 후 진행성 또는 재발성 활성 CIDP 성인 환자를 위해 설계되었습니다.
VYVGART는 CIDP를 위한 최초의 표적 IgG Fc-항체 조각이자 30년 만에 처음으로 새로운 작용 기전을 가진 치료제입니다. 이 권고는 지금까지 가장 큰 CIDP 환자 연구인 ADHERE 임상시험을 기반으로 합니다. 유럽 집행위원회의 결정은 2개월 내에 예상되며, EU 27개 회원국과 아이슬란드, 노르웨이, 리히텐슈타인에 적용됩니다.
Halozyme Therapeutics (NASDAQ : HALO) a annoncé qu’argenx a reçu un avis positif du CHMP recommandant l’approbation par la Commission européenne de VYVGART® avec ENHANZE® pour le traitement de la polyneuropathie inflammatoire démyélinisante chronique (CIDP). L’injection sous-cutanée, disponible en flacon ou en seringue préremplie, est destinée aux patients adultes atteints de CIDP active progressive ou récurrente après un traitement antérieur par corticostéroïdes ou immunoglobulines.
VYVGART représente le premier fragment d’anticorps IgG Fc ciblé pour la CIDP et le premier nouveau mécanisme d’action en plus de 30 ans. Cette recommandation repose sur l’essai clinique ADHERE, la plus grande étude à ce jour sur des patients atteints de CIDP. La décision de la Commission européenne, attendue dans les deux mois, s’appliquera aux 27 États membres de l’UE ainsi qu’à l’Islande, la Norvège et le Liechtenstein.
Halozyme Therapeutics (NASDAQ: HALO) gab bekannt, dass argenx eine positive CHMP-Empfehlung für die Zulassung von VYVGART® mit ENHANZE® durch die Europäische Kommission zur Behandlung der chronisch entzündlichen demyelinisierenden Polyneuropathie (CIDP) erhalten hat. Die subkutane Injektion, erhältlich als Fläschchen oder Fertigspritze, ist für erwachsene Patienten mit progredienter oder rezidivierender aktiver CIDP nach vorheriger Behandlung mit Kortikosteroiden oder Immunglobulinen vorgesehen.
VYVGART ist das erste zielgerichtete IgG-Fc-Antikörperfragment für CIDP und der erste neue Wirkmechanismus seit über 30 Jahren. Die Empfehlung basiert auf der ADHERE-Studie, der bisher größten klinischen Studie mit CIDP-Patienten. Die Entscheidung der Europäischen Kommission wird innerhalb von zwei Monaten erwartet und gilt für alle 27 EU-Mitgliedstaaten sowie Island, Norwegen und Liechtenstein.
- First novel CIDP treatment mechanism in 30+ years, indicating potential market leadership
- Positive CHMP opinion paves way for approval in 30 European countries
- Flexible administration options (vial/prefilled syringe) enhance market potential
- Backed by largest CIDP patient study to date (ADHERE trial)
- Final EC approval still pending
- Market entry dependent on successful European Commission decision
Insights
CHMP recommends EU approval of VYVGART with Halozyme's ENHANZE technology for CIDP, expanding commercial potential in 30 European countries.
This positive CHMP opinion represents a significant milestone for Halozyme's proprietary ENHANZE drug delivery technology platform. argenx's VYVGART subcutaneous injection, which incorporates Halozyme's recombinant human hyaluronidase enzyme (rHuPH20), has been recommended for approval in the EU for treating chronic inflammatory demyelinating polyneuropathy (CIDP).
The strategic importance of this development cannot be overstated. VYVGART with ENHANZE would be the first novel mechanism of action for CIDP treatment in more than 30 years, positioning it as a potentially groundbreaking therapy in this indication. The subcutaneous formulation enables self-administration by patients or caregivers, providing a significant convenience advantage over traditional treatments.
From a regulatory perspective, CHMP positive opinions typically lead to European Commission approval, which is expected within approximately two months. This would expand Halozyme's commercial footprint across 30 European countries (27 EU Member States plus Iceland, Norway, and Liechtenstein).
This recommendation validates Halozyme's business model of partnering its proprietary drug delivery technology with innovative therapeutics. CIDP is a chronic condition requiring ongoing treatment, suggesting potential for sustained utilization of ENHANZE technology if approved. The ADHERE clinical trial, described as the largest study of CIDP patients to date, provides robust clinical evidence supporting this application.
While the final EC decision is still pending, this regulatory progress strengthens Halozyme's position as a leading provider of subcutaneous drug delivery technology and expands the potential commercial applications of its ENHANZE platform.
European Commission (EC) decision on marketing authorization application expected within approximately two months
The SC injection of VYVGART® is available as a vial or prefilled syringe and can be administered by a patient, caregiver, or healthcare professional.
VYVGART is the first and only targeted IgG Fc-antibody fragment for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) and the first novel mechanism of action for CIDP treatment in more than 30 years.
"We are delighted that the subcutaneous injection of VYVGART® co-formulated with our ENHANZE drug delivery technology, has been recommended for approval in the European Union. The positive CHMP opinion moves argenx closer to offering patients throughout
The CHMP recommendation is based on positive results from the ADHERE clinical trial, the largest study of CIDP patients to date. For more information on the CHMP recommendation, and the ADHERE study and its findings, please view argenx's press release issued on April 28, 2025.
The EC is expected to make a decision following CHMP recommendation and the decision will apply to all 27 European Union Member States, and also to
About Halozyme
Halozyme is a biopharmaceutical company advancing disruptive solutions to improve patient experiences and outcomes for emerging and established therapies. As the innovators of ENHANZE® drug delivery technology with the proprietary enzyme rHuPH20, Halozyme's commercially-validated solution is used to facilitate the subcutaneous delivery of injected drugs and fluids, with the goal of improving the patient experience with rapid subcutaneous delivery and reduced treatment burden. Having touched one million patient lives in post-marketing use in ten commercialized products in at least one major region and across more than 100 global markets, Halozyme has licensed its ENHANZE® technology to leading pharmaceutical and biotechnology companies including Roche, Takeda, Pfizer, Janssen, AbbVie, Eli Lilly, Bristol-Myers Squibb, argenx, ViiV Healthcare, Chugai Pharmaceutical and Acumen Pharmaceuticals.
Halozyme also develops, manufactures and commercializes, for itself or with partners, drug-device combination products using its advanced auto-injector technologies that are designed to provide commercial or functional advantages such as improved convenience, reliability and tolerability, and enhanced patient comfort and adherence. The Company has two commercial proprietary products, Hylenex® and XYOSTED®, partnered commercial products and ongoing product development programs with Teva Pharmaceuticals and McDermott Laboratories Limited, an affiliate of Viatris Inc.
Halozyme is headquartered in
For more information visit www.halozyme.com and connect with us on LinkedIn and Twitter.
Safe Harbor Statement
In addition to historical information, the statements set forth above include forward-looking statements including, without limitation, statements concerning the possible activity, benefits and attributes of ENHANZE®, the possible method of action of ENHANZE®, its potential application to aid in the dispersion and absorption of other injected therapeutic drugs, and statements concerning certain other potential benefits of ENHANZE® including facilitating more rapid delivery of injectable medications through subcutaneous delivery and potentially lowering the treatment burden for patients, including a potential reduction in administration time and broadening the treatment options for the indication referred to in this press release. Forward-looking statements may also include statements regarding the product development efforts of Halozyme's ENHANZE® partner and the potential approval of an extension of marketing authorization for the subcutaneous formulation referred to in this press release and the timing of such potential approval. These forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. The forward-looking statements are typically, but not always, identified through use of the words "expect," "believe," "enable," "may," "will," "could," "intends," "estimate," "anticipate," "plan," "predict," "probable," "potential," "possible," "should," "continue," and other words of similar meaning. Actual results could differ materially from the expectations contained in forward-looking statements as a result of several factors, including uncertainties concerning whether the extension of marketing authorization for the subcutaneous formulation referred to in this press release is delayed or ultimately approved, unexpected results or delays in the launch or commercialization of our partner's product for the indication referred to in this press release, unexpected adverse events or patient experiences or outcomes from being treated with the ENHANZE® co-formulated treatment referred to in this press release, and competitive conditions. These and other factors that may result in differences are discussed in greater detail in Halozyme's most recent Annual and Quarterly Reports filed with the Securities and Exchange Commission. Except as required by law, Halozyme undertakes no duty to update forward-looking statements to reflect events after the date of this release.
Contacts:
Tram Bui
VP, Investor Relations and Corporate Communications
609-333-7668
tbui@halozyme.com
Samantha Gaspar
Teneo
212-886-9356
samantha.gaspar@teneo.com
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SOURCE Halozyme Therapeutics, Inc.
FAQ
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