Subcutaneous Ocrevus gets UK approval for relapsing MS, PPMS
Time-saving treatment expected to be available within weeks
A subcutaneous, or under-the-skin, formulation of Ocrevus (ocrelizumab) received approval from the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) to treat adults with multiple sclerosis (MS).
The approval means that people with relapsing forms of MS and those with primary progressive MS (PPMS) will now be able to receive Ocrevus via an under-the-skin injection that takes 10 minutes. This will cut treatment time by about 90%, as the older formulation is given via an intravenous, or into-the-vein, infusion that can take up to four hours.
“Enabling safe access to high quality, safe and effective medical products are key priorities for us,” Shirley Hopper, MHRA’s deputy director of innovative medicines, said in an agency press release. “We’re assured that the appropriate regulatory standards of safety, quality and effectiveness for the approval of this new formulation have been met.”
Genentech‘s newer formulation will be given to eligible patients in England via the country’s National Health Service (NHS). It’s expected to be available in the coming weeks.
“Ocrelizumab has represented a huge advance in care in recent years as the first drug able to change the course of the disease, and we hope this innovative and speedier option will now make another significant difference in improving patients’ quality of life and help thousands avoid longer stints in hospital for treatment,” Stephen Powis, NHS national medical director, said in an NHS press release.
Approved in EU, under consideration in US
The subcutaneous version of Ocrevus was approved in the European Union last month and is being considered for approval in the U.S., where a decision is expected by September.
Ocrevus is an antibody-based therapy that works by selectively targeting and eliminating B-cells, a particular type of immune cell that contributes to the inflammatory attack that drives MS. It has been shown in multiple clinical trials and real-word studies to significantly reduce the number of relapses, prevent the development of new lesions, and slow disability progression.
The drug is administered via an intravenous infusion every six months, following two initial infusions given two weeks apart. Each infusion lasts two to four hours.
Subcutaneous Ocrevus was developed to provide a more convenient administration method. The injections still have to be given by a doctor or nurse, but can be done outside the clinic.
“This new injection will drastically cut the time that regular treatment takes for those living with multiple sclerosis, meaning that thousands of patients can spend less time in hospital while helping free up clinicians’ time to see more patients,” Powis said.
MHRA’s approval of under-the-skin Ocrevus was based on data from the Phase 3 OCARINA II trial (NCT05232825), which showed the subcutaneous treatment was just as effective as the intravenous formulation.
The trial enrolled 236 adults with PPMS or relapsing forms of MS who were randomly assigned to receive an initial 920 mg dose of the subcutaneous formulation or the approved 600 mg intravenous dose that’s given two weeks apart.
After a follow-up period of about six months, all patients received the subcutaneous formulation every six months for up to about two years.
Results showed that both formulations were well tolerated and led to similar decreases in B-cells. After about one year, the vast majority of patients in both groups were free from relapses — 97.2% with the subcutaneous formulation and 98.1% with intravenous Ocrevus — and most had no inflammatory lesions or new or enlarging lesions.
The majority of patients (92.3%) also reported high levels of satisfaction with the new formulation and said the injection formulation was convenient or very convenient (90.1%).
The most common side effects of subcutaneous Ocrevus were injection reactions, including redness, pain, swelling, and itching, which were reported in over half of all patients. Still, these reactions were all mild to moderate and did not cause patients to cease treatment.
Due to the suppressive effect of Ocrevus on the immune system, treatment is also associated with an increased risk of infections. Patients who suspect they are experiencing a side effect should consult with a medical professional and report it directly to the Yellow Card program, the U.K. system for reporting adverse events with medicines or medical devices, either through the Yellow Card website or its app (available via Apple or Google Play).
“As with all products, we will keep its safety under close review,” said Hopper.
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