FDA Approves Ocrevus Zunovo for Relapsing, Primary-Progressive Multiple Sclerosis

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The FDA has approved Roche’s Ocrevus Zunovo (ocrelizumab & hyaluronidase-ocsq) as the first and only twice-yearly, 10-minute subcutaneous (SC) injection for treating both relapsing multiple sclerosis (RMS) and primary-progressive multiple sclerosis (PPMS). The regulatory action was based on findings from the Phase III OCARINA II trial, which demonstrated equivalent levels of Ocrevus in the blood, comparable safety and efficacy profiles, and high patient satisfaction.¹

“Ocrevus Zunovo gives patients and providers another option for receiving Ocrevus, building on a decade of robust safety and efficacy data for Ocrevus in multiple sclerosis,” said Levi Garraway, MD, PhD, chief medical officer, head, global product development, Roche, in a press release. “This approval may offer greater flexibility for healthcare providers and people living with multiple sclerosis, based on their individual treatment needs.”

The global multicenter, randomized OCARINA II study evaluated the pharmacokinetics, safety, and clinical and radiological efficacy of the SC formulation of Ocrevus compared to Ocrevus intravenous (IV) infusion. The trial included 236 patients with RMS or PPMS, with a primary endpoint of non-inferiority with SC formulation compared to the IV version based on Ocrevus levels in the blood, while the secondary endpoint was consistent control of clinical and radiological disease activity.

Results found that Ocrevus Zunovo effectively suppressed relapse activity and MRI lesions by 97% over 48 weeks, demonstrating consistency with the IV formulation. Additionally, 92% of trial participants reported being satisfied or very satisfied with the SC administration of the treatment.

Forty-nine percent of trial participants experienced injection reactions after the first injection ranging from mild to moderate, with none leading to treatment withdrawal.¹ These include adverse events (AEs) such as pruritus; rash; urticaria; erythema; bronchospasm; throat irritation; oropharyngeal pain; dyspnea; pharyngeal or laryngeal edema; flushing, hypotension; pyrexia; fatigue; headache; dizziness; nausea; tachycardia; and anaphylaxis. Roche warns that infusion reactions can occur up to 24 hours after the infusion. Life-threatening or fatal AEs such as bacterial, viral, parasitic and fungal infections have been reported in patients receiving Ocrevus.²

According to the National Multiple Sclerosis Society, an estimated one million people in the United States have received a diagnosis of MS to date. It is estimated that globally, 2.8 million people are currently living with some form of MS. Last year, the National MS Society also supported a study that determined the prevalence of MS throughout the United States. Results found that for every 1,000 people, the following groups may have MS:

• Around four white people that who are not Hispanic/Latinx.
• Around three black people who are not Hispanic/Latinx.
• Around 1.5 Hispanic/Latinx people.
• Around two in other races, such as Asians, Native Americans, Alaska natives and people of several races.³

“People are living longer with chronic illnesses and with fewer disabilities because of the extensive progress that has been made in the development of medicines that can slow their progression,” said Natalie Blake, executive director, MS Foundation, in the press release. “But still, not everyone has access to these medicines. It’s crucial to acknowledge each experience with MS is as unique as the individual navigating it, so providing choices to address each person’s needs is essential. We are pleased that with a new method of delivery, there is now an additional option for those who need flexibility in the route of administration or treatment time.”

References

1. FDA approves OCREVUS ZUNOVO™ as the first and only twice-a-year 10-minute subcutaneous injection for people with relapsing and progressive multiple sclerosis. Roche. September 16, 2024. Accessed September 16, 2024. https://www.roche.com/media/releases/med-cor-2024-09-16

2. Indications and Important Safety Information for HCPs. Ocrevus. Accessed September 16, 2024. https://www.ocrevus-hcp.com/safety.html?c=ocr-16ff2075cbd&gclid=Cj0KCQjwrp-3BhDgARIsAEWJ6SzprP8PSe_CzvMQ8_T_8sC0Z-hbLWbuSo7M3dWroLpf2NeDCLo0MosaAhLpEALw_wcB&gclsrc=aw.ds

3. MS Prevalence. National Multiple Sclerosis Society. Accessed September 16, 2024. https://www.nationalmssociety.org/about-the-society/who-we-are/research-we-fund/ms-prevalence#:~:text=Prevalence%20of%20MS,in%20the%20world%20have%20MS.