Halozyme Announces FDA Approval of argenx's VYVGART® Hytrulo Prefilled Syringe Co-Formulated with ENHANZE® for Self-Injection for Generalized Myasthenia Gravis and Chronic Inflammatory Demyelinating Polyneuropathy
Halozyme Therapeutics (NASDAQ: HALO) announced FDA approval of VYVGART® Hytrulo prefilled syringe for self-injection, co-formulated with ENHANZE® technology. The treatment is approved for adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor antibody positive and adults with chronic inflammatory demyelinating polyneuropathy (CIDP).
The new prefilled syringe enables a 20-to-30-second subcutaneous self-injection, allowing patients to self-administer after proper training. This development stems from argenx's exclusive partnership with Halozyme's ENHANZE® drug delivery technology. The approval is supported by bioequivalence studies comparing the prefilled syringe to VYVGART® Hytrulo in vial form, along with human factors validation studies demonstrating successful administration by gMG and CIDP patients or their caregivers.
Halozyme Therapeutics (NASDAQ: HALO) ha annunciato l'approvazione da parte della FDA della siringa pre-riempita VYVGART® Hytrulo per auto-iniezione, co-formulata con la tecnologia ENHANZE®. Il trattamento è approvato per pazienti adulti con miastenia gravis generalizzata (gMG) che sono positivi agli anticorpi contro il recettore dell'acetilcolina e per adulti con neuropatia periferica demielinizzante infiammatoria cronica (CIDP).
La nuova siringa pre-riempita consente un'auto-iniezione sottocutanea in 20-30 secondi, permettendo ai pazienti di auto-somministrarsi dopo un'adeguata formazione. Questo sviluppo deriva dalla partnership esclusiva di argenx con la tecnologia di somministrazione dei farmaci ENHANZE® di Halozyme. L'approvazione è supportata da studi di bioequivalenza che confrontano la siringa pre-riempita con VYVGART® Hytrulo in forma di fiala, insieme a studi di validazione dei fattori umani che dimostrano la somministrazione riuscita da parte di pazienti gMG e CIDP o dei loro caregiver.
Halozyme Therapeutics (NASDAQ: HALO) anunció la aprobación de la FDA de la jeringa precargada VYVGART® Hytrulo para auto-inyección, co-formulada con la tecnología ENHANZE®. El tratamiento está aprobado para pacientes adultos con miastenia gravis generalizada (gMG) que son positivos para los anticuerpos del receptor de acetilcolina y adultos con neuropatía desmielinizante inflamatoria crónica (CIDP).
La nueva jeringa precargada permite una auto-inyección subcutánea en 20 a 30 segundos, permitiendo a los pacientes auto-administrarse después de una adecuada capacitación. Este desarrollo proviene de la asociación exclusiva de argenx con la tecnología de administración de medicamentos ENHANZE® de Halozyme. La aprobación está respaldada por estudios de bioequivalencia que comparan la jeringa precargada con VYVGART® Hytrulo en forma de vial, junto con estudios de validación de factores humanos que demuestran la administración exitosa por parte de pacientes gMG y CIDP o sus cuidadores.
Halozyme Therapeutics (NASDAQ: HALO)는 자가 주사를 위한 VYVGART® Hytrulo 프리필드 주사기의 FDA 승인을 발표했습니다. 이 주사기는 ENHANZE® 기술과 함께 공동 조제되었습니다. 이 치료법은 일반화된 중증근무력증 (gMG) 환자 중 항아세틸콜린 수용체 항체 양성인 성인과 만성 염증성 탈수초성 다발신경병증 (CIDP) 성인에게 승인되었습니다.
새로운 프리필드 주사기는 20-30초 만에 피하 자가 주사를 가능하게 하여, 환자가 적절한 교육 후 자가 투여를 할 수 있도록 합니다. 이 개발은 argenx의 Halozyme의 ENHANZE® 약물 전달 기술과의 독점 파트너십에서 비롯되었습니다. 승인은 프리필드 주사기와 바이알 형태의 VYVGART® Hytrulo를 비교한 생물학적 동등성 연구와 gMG 및 CIDP 환자 또는 그 보호자가 성공적으로 투여한 것을 입증하는 인간 요인 검증 연구에 의해 뒷받침됩니다.
Halozyme Therapeutics (NASDAQ: HALO) a annoncé l'approbation par la FDA de la seringue préremplie VYVGART® Hytrulo pour auto-injection, co-formulée avec la technologie ENHANZE®. Le traitement est approuvé pour les patients adultes atteints de myasthénie grave généralisée (gMG) qui sont positifs aux anticorps du récepteur de l'acétylcholine et pour les adultes atteints de neuropathie démyélinisante inflammatoire chronique (CIDP).
La nouvelle seringue préremplie permet une auto-injection sous-cutanée en 20 à 30 secondes, permettant aux patients de s'auto-administrer après une formation appropriée. Ce développement découle du partenariat exclusif d'argenx avec la technologie de délivrance de médicaments ENHANZE® de Halozyme. L'approbation est soutenue par des études de bioéquivalence comparant la seringue préremplie à VYVGART® Hytrulo sous forme de flacon, ainsi que par des études de validation des facteurs humains démontrant une administration réussie par des patients gMG et CIDP ou leurs aidants.
Halozyme Therapeutics (NASDAQ: HALO) gab die FDA-Zulassung der VYVGART® Hytrulo Fertigspritze zur Selbstinjektion bekannt, die mit der ENHANZE®-Technologie ko-formuliert wurde. Die Behandlung ist für erwachsene Patienten mit generalisierten Myasthenia gravis (gMG), die positiv auf Antikörper gegen den Acetylcholinrezeptor getestet wurden, sowie für Erwachsene mit chronischer entzündlicher demyelinisierender Polyneuropathie (CIDP) zugelassen.
Die neue Fertigspritze ermöglicht eine subkutane Selbstinjektion in 20 bis 30 Sekunden, sodass Patienten sich nach entsprechender Schulung selbst behandeln können. Diese Entwicklung stammt aus der exklusiven Partnerschaft von argenx mit der ENHANZE®-Medikamentenabgabetechnologie von Halozyme. Die Zulassung wird durch Bioäquivalenzstudien gestützt, die die Fertigspritze mit VYVGART® Hytrulo in Flaschenform vergleichen, sowie durch Studien zur Validierung menschlicher Faktoren, die eine erfolgreiche Verabreichung durch gMG- und CIDP-Patienten oder deren Betreuer belegen.
- FDA approval expands treatment accessibility through self-administration option
- Significantly reduced administration time (20-30 seconds) improves patient convenience
- Partnership with argenx demonstrates successful commercialization of ENHANZE technology
- None.
Insights
The FDA approval of argenx's VYVGART® Hytrulo prefilled syringe represents a significant commercial expansion for Halozyme's ENHANZE® drug delivery technology. This approval adds substantial value to Halozyme's partnership with argenx by enabling patient self-administration - a key differentiator in the competitive autoimmune disease market.
This development is noteworthy for several reasons. First, the 20-30 second administration time offers dramatic improvement over traditional IV infusions that can take hours. Second, this advances Halozyme's business model of generating revenues through technology licensing and subsequent royalties on partner product sales. Their ENHANZE® technology, which uses recombinant human hyaluronidase PH20 enzyme, enables biologics to be delivered subcutaneously rather than intravenously.
For Halozyme investors, this represents expanded recurring revenue potential as the prefilled syringe formulation could increase therapy adoption for both gMG and CIDP indications. The approval also validates Halozyme's strategy of leveraging their proprietary technology across multiple therapeutic areas through strategic partnerships.
While the article doesn't specify financial terms, Halozyme typically receives milestone payments upon regulatory approvals plus mid-single digit royalties on sales of partnered products using ENHANZE®. This approval strengthens Halozyme's competitive position in drug delivery technology and reinforces the company's growth trajectory in enabling patient-friendly administration options.
VYVGART® Hytrulo prefilled syringe for self-injection is approved as a 20-to-30-second subcutaneous injection administered by a patient, caregiver, or healthcare professional. Patients are able to self-inject after proper instruction in subcutaneous injection technique.
The single dose prefilled subcutaneous injection was developed as part of argenx's exclusive partnership with Halozyme on their ENHANZE® drug delivery technology, which enables rapid, high-volume delivery of biologics
"The FDA approval of VYVGART Hytrulo prefilled syringe represents a significant advancement in treatment options for gMG and CIDP patients, enabling self-administration by patients and potentially further reducing the burden of treatment," said Dr. Helen Torley, president and chief executive officer of Halozyme. "We are delighted that argenx continues to expand use of Halozyme's proven ENHANZE technology to support patient independence and convenience."
The approval of VYVGART® Hytrulo prefilled syringe for self-injection is supported by data from studies evaluating its bioequivalence to VYVGART® Hytrulo in a vial. In addition, human factors validation studies demonstrated that participants with gMG or CIDP, or their caregivers, safely and successfully prepared and administered VYVGART® Hytrulo with the prefilled syringe. Previous FDA approval of VYVGART® Hytrulo for patients with gMG and CIDP was based on the global Phase 3 ADAPT, ADAPT-SC and ADHERE trials.
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 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 Idorsia Pharmaceuticals.
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 offering flexibility to receive treatment in more convenient locations by enabling self-administration and broadening the treatment options for the indication referred to in this press release. 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 unexpected results or delays in launch or commercialization of our partner's product 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
View original content to download multimedia:https://www.prnewswire.com/news-releases/halozyme-announces-fda-approval-of-argenxs-vyvgart-hytrulo-prefilled-syringe-co-formulated-with-enhanze-for-self-injection-for-generalized-myasthenia-gravis-and-chronic-inflammatory-demyelinating-polyneuropathy-302426123.html
SOURCE Halozyme Therapeutics, Inc.
FAQ
What conditions is VYVGART Hytrulo prefilled syringe approved to treat?
How long does it take to administer VYVGART Hytrulo's new self-injection format?
What clinical data supported the FDA approval of VYVGART Hytrulo prefilled syringe?
What technology enables VYVGART Hytrulo's rapid subcutaneous delivery?
