Halozyme Announces Bristol Myers Squibb Received European Commission Approval for Subcutaneous Opdivo® (nivolumab) Co-Formulated with ENHANZE® Across Multiple Solid Tumor Indications
Halozyme Therapeutics (NASDAQ: HALO) announced that Bristol Myers Squibb has received European Commission approval for a subcutaneous formulation of Opdivo® (nivolumab) developed with Halozyme's ENHANZE® technology. The approval covers multiple adult solid tumor indications and makes Opdivo® the first and only PD-1 inhibitor approved for subcutaneous use in the European Union.
The new formulation allows for a 3-to-5-minute subcutaneous injection, offering a more convenient alternative to traditional administration methods. The approval is supported by the Phase 3 CheckMate -67T trial and is valid across all 27 EU member states, plus Iceland, Liechtenstein and Norway. This follows the U.S. FDA approval of Opdivo Qvantig™ in December 2024.
Halozyme Therapeutics (NASDAQ: HALO) ha annunciato che Bristol Myers Squibb ha ottenuto l'approvazione della Commissione Europea per una formulazione sottocutanea di Opdivo® (nivolumab) sviluppata con la tecnologia ENHANZE® di Halozyme. L'approvazione riguarda diverse indicazioni per tumori solidi negli adulti e rende Opdivo® il primo e unico inibitore PD-1 approvato per uso sottocutaneo nell'Unione Europea.
La nuova formulazione consente un'iniezione sottocutanea della durata di 3-5 minuti, offrendo un'alternativa più comoda ai metodi di somministrazione tradizionali. L'approvazione si basa sullo studio di fase 3 CheckMate -67T ed è valida in tutti i 27 stati membri dell'UE, oltre che in Islanda, Liechtenstein e Norvegia. Questo segue l'approvazione da parte della FDA statunitense di Opdivo Qvantig™ a dicembre 2024.
Halozyme Therapeutics (NASDAQ: HALO) anunció que Bristol Myers Squibb ha recibido la aprobación de la Comisión Europea para una formulación subcutánea de Opdivo® (nivolumab) desarrollada con la tecnología ENHANZE® de Halozyme. La aprobación cubre múltiples indicaciones para tumores sólidos en adultos y convierte a Opdivo® en el primer y único inhibidor de PD-1 aprobado para uso subcutáneo en la Unión Europea.
La nueva formulación permite una inyección subcutánea de 3 a 5 minutos, ofreciendo una alternativa más conveniente a los métodos tradicionales de administración. La aprobación está respaldada por el ensayo de fase 3 CheckMate -67T y es válida en los 27 estados miembros de la UE, además de Islandia, Liechtenstein y Noruega. Esto sigue a la aprobación de la FDA de EE.UU. para Opdivo Qvantig™ en diciembre de 2024.
Halozyme Therapeutics (NASDAQ: HALO)는 Bristol Myers Squibb가 Halozyme의 ENHANZE® 기술로 개발된 Opdivo® (nivolumab) 피하 투여 제형에 대해 유럽연합 집행위원회 승인을 받았다고 발표했습니다. 이번 승인은 여러 성인 고형암 적응증을 포함하며, Opdivo®를 유럽연합에서 피하 투여가 승인된 최초이자 유일한 PD-1 억제제로 만듭니다.
새 제형은 3~5분간의 피하 주사를 가능하게 하여 기존 투여 방식보다 더 편리한 대안을 제공합니다. 이 승인은 3상 CheckMate -67T 임상시험을 기반으로 하며, EU 27개 회원국과 아이슬란드, 리히텐슈타인, 노르웨이에서 유효합니다. 이는 2024년 12월 미국 FDA의 Opdivo Qvantig™ 승인에 이은 것입니다.
Halozyme Therapeutics (NASDAQ : HALO) a annoncé que Bristol Myers Squibb a obtenu l'approbation de la Commission européenne pour une formulation sous-cutanée de Opdivo® (nivolumab) développée avec la technologie ENHANZE® de Halozyme. Cette approbation couvre plusieurs indications pour les tumeurs solides chez l'adulte et fait d'Opdivo® le premier et unique inhibiteur de PD-1 approuvé pour une utilisation sous-cutanée dans l'Union européenne.
La nouvelle formulation permet une injection sous-cutanée de 3 à 5 minutes, offrant une alternative plus pratique aux méthodes d'administration traditionnelles. L'approbation est soutenue par l'essai de phase 3 CheckMate -67T et est valable dans les 27 États membres de l'UE, ainsi qu'en Islande, au Liechtenstein et en Norvège. Cela fait suite à l'approbation par la FDA américaine d'Opdivo Qvantig™ en décembre 2024.
Halozyme Therapeutics (NASDAQ: HALO) gab bekannt, dass Bristol Myers Squibb die Zulassung der Europäischen Kommission für eine subkutane Formulierung von Opdivo® (Nivolumab) erhalten hat, die mit der ENHANZE®-Technologie von Halozyme entwickelt wurde. Die Zulassung umfasst mehrere Indikationen bei soliden Tumoren bei Erwachsenen und macht Opdivo® zum ersten und einzigen PD-1-Inhibitor, der für die subkutane Anwendung in der Europäischen Union zugelassen ist.
Die neue Formulierung ermöglicht eine 3- bis 5-minütige subkutane Injektion und bietet eine bequemere Alternative zu traditionellen Verabreichungsmethoden. Die Zulassung basiert auf der Phase-3-Studie CheckMate -67T und gilt in allen 27 EU-Mitgliedstaaten sowie in Island, Liechtenstein und Norwegen. Dies folgt auf die Zulassung von Opdivo Qvantig™ durch die US-FDA im Dezember 2024.
- First and only PD-1 inhibitor approved for subcutaneous use in the EU
- Represents one of 11 growth catalysts expected for Halozyme's commercialized SC products this year
- Approval extends across multiple solid tumor indications
- Expands geographic reach following previous U.S. FDA approval
- None.
Opdivo® is the first and only PD-1 inhibitor approved for subcutaneous (SC) use in the European Union
"The European approval of Opdivo SC represents an advancement for certain cancer patients, who now have the option to receive their Opdivo as a 3-to-5-minute SC injection," said Dr. Helen Torley, president and chief executive officer of Halozyme. "This approval is just one of the 11 growth catalysts for our commercialized SC products expected this year."
The positive EC decision is supported by positive results from the Phase 3 CheckMate -67T trial. For more information on the study and its findings, please view Bristol Myers Squibb's press release issued on May 28, 2025.
The approval by the EC is valid in all 27 member states of the European Union (EU), as well as
On December 27, 2024, subcutaneous nivolumab and hyaluronidase-nvhy, marketed under the brand name Opdivo Qvantig™, was approved by the
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 indications referred to in this press release. Forward-looking statements may also include statements regarding potential growth catalysts and opportunities driven by the product development and commercialization efforts of Halozyme's ENHANZE® partners. 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 unexpected results or delays in the timing of the Company's expected growth catalysts or in the launch or commercialization of our partner's product for the indications 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.
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