Back-To-Back FDA Approvals For Roche's Two Under-The-Skin Injections

Monday, the FDA approved Roche Holdings AG’s RHHBY Ocrevus Zunovo (ocrelizumab & hyaluronidase-ocsq) for relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS).

Ocrevus Zunovo is the first and only twice-a-year healthcare professional (HCP)-administered approximately 10-minute subcutaneous (SC) injection approved for both forms of multiple sclerosis.

The FDA approval is based on data from the Phase 3 OCARINA 2 trial, which showed no clinically significant difference in the levels of Ocrevus in the blood when administered subcutaneously and a safety and efficacy profile consistent with the IV formulation in people with RMS and PPMS.

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In the Phase 2 OCARINA 2 trial, the safety profile of Ocrevus Zunovo was consistent with the well-established safety profile of Ocrevus IV, except for injection reactions.

Just on Friday, the FDA also approved Roche’s Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs), the first and only PD-(L)1 inhibitor for subcutaneous (SC), under the skin injection for patients in the U.S.

Tecentriq Hybreza can be injected subcutaneously over approximately seven minutes, compared with 30-60 minutes for standard intravenous (IV) infusion of Tecentriq (atezolizumab).

It will be available for all IV indications of Tecentriq approved for adults in the U.S., including certain types of lung, liver, skin, and soft tissue cancer.

The FDA approval is based on Phase 1B/3 IMscin001 study data, which showed comparable levels of Tecentriq in the blood when administered subcutaneously and a safety and efficacy profile consistent with the IV formulation.

The Phase 2 IMscin002 study showed that 71% of patients preferred Tecentriq Hybreza over intravenous atezolizumab.

The subcutaneous formulation of Tecentriq received its first worldwide approval in Great Britain in August 2023 and is now approved in 50 countries (outside the U.S., marketed as Tecentriq SC).

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