Halozyme Announces FDA Approval of Roche's Subcutaneous OCREVUS ZUNOVO™ with ENHANZE® for People with Relapsing and Primary Progressive Multiple Sclerosis
Halozyme Therapeutics (NASDAQ: HALO) announced FDA approval of Roche's OCREVUS ZUNOVO™, a subcutaneous formulation incorporating Halozyme's ENHANZE® technology, for treating relapsing and primary progressive multiple sclerosis. This new formulation offers a twice-yearly, 10-minute injection, expanding treatment options to centers without IV infrastructure. The approval is based on the Phase III OCARINA II trial, which demonstrated non-inferior blood levels and a comparable safety and efficacy profile to the IV formulation. The subcutaneous version showed 97% suppression of relapse activity and MRI lesions through 48 weeks, with over 92% of patients reporting satisfaction with the administration method.
Halozyme Therapeutics (NASDAQ: HALO) ha annunciato l'approvazione da parte della FDA del OCREVUS ZUNOVO™ di Roche, una formulazione sottocutanea che incorpora la tecnologia ENHANZE® di Halozyme, per il trattamento della sclerosi multipla recidivante e progressiva primaria. Questa nuova formulazione offre un'iniezione di 10 minuti, due volte l'anno, ampliando le opzioni di trattamento per i centri privi di infrastrutture IV. L'approvazione si basa sui risultati dello studio di Fase III OCARINA II, che ha dimostrato livelli ematici non inferiori e un profilo di sicurezza ed efficacia comparabile alla formulazione IV. La versione sottocutanea ha mostrato una soppressione del 97% dell'attività di ricaduta e delle lesioni da MRI dopo 48 settimane, con oltre il 92% dei pazienti che ha riportato soddisfazione rispetto al metodo di somministrazione.
Halozyme Therapeutics (NASDAQ: HALO) anunció la aprobación de la FDA del OCREVUS ZUNOVO™ de Roche, una formulación subcutánea que incorpora la tecnología ENHANZE® de Halozyme, para el tratamiento de la esclerosis múltiple recurrente y progresiva primaria. Esta nueva formulación ofrece una inyección de 10 minutos, dos veces al año, ampliando las opciones de tratamiento para centros sin infraestructura IV. La aprobación se basa en el ensayo de fase III OCARINA II, que demostró niveles sanguíneos no inferiores y un perfil de seguridad y eficacia comparable al de la formulación IV. La versión subcutánea mostró una supresión del 97% de la actividad de recaída y de las lesiones por RM a través de 48 semanas, con más del 92% de los pacientes reportando satisfacción con el método de administración.
Halozyme Therapeutics (NASDAQ: HALO)는 Roche의 OCREVUS ZUNOVO™에 대한 FDA 승인을 발표했습니다. 이 약물은 Halozyme의 ENHANZE® 기술을 활용한 피하 주사 형태로, 재발성 및 일차 진행성 다발성 경화증 치료에 사용됩니다. 이 새로운 제형은 1년에 두 번, 10분 주사를 제공하여 IV 인프라가 없는 센터에서도 치료 옵션을 확대합니다. 승인된 근거는 혈중 농도가 비열등함을 보여주었고 IV 제형에 비해 비교 가능한 안전성 및 유효성 프로필을 가지고 있는 Phase III OCARINA II 시험 결과입니다. 피하 제형은 48주 동안 재발 활동과 MRI 병변의 97% 억제를 보였으며, 92% 이상의 환자가 투여 방법에 대해 만족한다고 보고했습니다.
Halozyme Therapeutics (NASDAQ: HALO) a annoncé l'approbation par la FDA du OCREVUS ZUNOVO™ de Roche, une formulation sous-cutanée intégrant la technologie ENHANZE® de Halozyme, pour le traitement de la sclérose en plaques récurrente et progressive primaire. Cette nouvelle formulation offre une injection de 10 minutes, deux fois par an, élargissant les options de traitements pour les centres sans infrastructure IV. L'approbation est basée sur l'essai de phase III OCARINA II, qui a démontré des niveaux sanguins non inférieurs et un profil de sécurité et d'efficacité comparable à la formulation IV. La version sous-cutanée a montré une suspension de 97 % de l'activité de rechute et des lésions par IRM sur 48 semaines, avec plus de 92 % des patients déclarant être satisfaits de la méthode d'administration.
Halozyme Therapeutics (NASDAQ: HALO) gab die FDA-Zulassung von Roches OCREVUS ZUNOVO™ bekannt, einer subkutanen Formulierung, die die ENHANZE®-Technologie von Halozyme verwendet, zur Behandlung von schubförmiger und primär progredienter Multipler Sklerose. Diese neue Formulierung bietet eine 10-minütige Injektion, die zweimal jährlich erfolgt, und erweitert die Behandlungsmöglichkeiten für Zentren ohne IV-Infrastruktur. Die Genehmigung basiert auf der Phase-III-Studie OCARINA II, die nicht unterlegene Blutspiegel und ein vergleichbares Sicherheits- und Wirksamkeitsprofil zur IV-Formulierung nachwies. Die subkutane Version zeigte eine 97%ige Unterdrückung der Rückfallaktivität und der MRI-Läsionen über einen Zeitraum von 48 Wochen, wobei über 92% der Patienten mit der Anwendungsmethode zufrieden waren.
- FDA approval of OCREVUS ZUNOVO™ for multiple sclerosis treatment
- Expansion of treatment options to centers without IV infrastructure
- Comparable efficacy to IV formulation with 97% suppression of relapse activity and MRI lesions
- High patient satisfaction (92%) with subcutaneous administration
- Potential for increased market penetration due to simplified administration
- Potential for injection site reactions, although reported as mild to moderate
Insights
The FDA approval of OCREVUS ZUNOVO™ marks a significant advancement in multiple sclerosis (MS) treatment. This subcutaneous formulation, utilizing Halozyme's ENHANZE® technology, offers a 10-minute injection alternative to the traditional IV infusion. The non-inferior efficacy and comparable safety profile to the IV form, as demonstrated in the OCARINA II trial, are particularly noteworthy.
Key points to consider:
- High patient satisfaction (
92% ) with SC administration - Consistent suppression of relapse activity and MRI lesions (
97% for both) - Potential for expanded treatment access in centers without IV infrastructure
This approval could reshape MS treatment paradigms, potentially improving patient convenience and adherence while maintaining efficacy. However, long-term real-world data will be important to confirm these initial positive outcomes.
This FDA approval is a significant milestone for Halozyme, potentially boosting its revenue stream through increased adoption of its ENHANZE® technology. Key financial implications include:
- Expanded market reach for OCREVUS, now accessible to centers without IV capabilities
- Potential for increased royalties from Roche, depending on sales performance
- Enhanced value proposition of ENHANZE® technology, possibly attracting new partnerships
While specific financial projections aren't provided, this approval strengthens Halozyme's position in the drug delivery market. Investors should monitor OCREVUS ZUNOVO™'s market penetration and its impact on Halozyme's royalty revenues. The company's future guidance and quarterly reports will be important in assessing the financial impact of this approval.
OCREVUS ZUNOVO™ has the potential to expand treatment options to centers without IV infrastructure or with IV constraints
"We are pleased that the subcutaneous formulation of OCREVUS, OCREVUS ZUNOVO, which contains our ENHANZE drug delivery technology, is now approved in the
The FDA approval is based on pivotal data from the Phase III OCARINA II trial, which showed non-inferior levels of OCREVUS in the blood when administered subcutaneously, and a safety and efficacy profile comparable to the intravenous (IV) formulation in people with RMS and PPMS. The most common adverse events with OCREVUS ZUNOVO were injection reactions, all of which were either mild or moderate, and none of which led to treatment withdrawal. Out of the exploratory outcomes measured, OCREVUS ZUNOVO was consistent with IV, demonstrating suppression of relapse activity (
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 more than 800,000 patient lives in post-marketing use in eight 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 several pharmaceutical companies including 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 and broadening the treatment options for the indications 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 "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 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.
OCREVUS ZUNOVO™ is a trademark of Genentech, a member of the Roche Group.
Contacts:
Tram Bui
VP, Investor Relations and Corporate Communications
609-359-3016
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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