Issued by: Medicines and Healthcare products Regulatory Agency

The Medicines and Healthcare products Regulatory Agency (MHRA) has approved a new formulation of the medicine ocrelizumab (Ocrevus 920mg solution for injection) to treat relapsing forms of multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS) in adults.

Multiple sclerosis (MS) is a condition that can affect the brain and spinal cord, causing a wide range of potential symptoms, including problems with vision, arm or leg movement, sensation or balance. It is a lifelong condition that can sometimes cause disability, although it can occasionally be mild.

Ocrelizumab can be used in two types of patients:

- Adults with RMS, where the patient has flare-ups (relapses) followed by periods with mild or no symptoms;

- Adults with PPMS, where symptoms get steadily worse over time.

The active ingredient ocrelizumab was previously approved in the United Kingdom in 2018, administered as an infusion (drip) into a vein. The first two infusions are given two weeks apart and subsequent infusions every six months.

The approval of this formulation will enable patients to receive a total dose of 920mg of Ocrevus every six months, administered by a doctor or nurse as a subcutaneous injection.

Ocrelizumab works by attaching to specific B cells, which are a type of white blood cell that are part of the immune system and play a role in MS. Ocrelizumab targets and removes these specific B cells, which reduces inflammation and attacks on the myelin sheaths around nerves, thereby reducing the chance of having a relapse and slowing the progression of the disease.

In patients with RMS, ocrelizumab helps to significantly reduce the number of relapses, significantly slows down the progression of disease and increases the chances of a patient showing no evidence of disease activity (brain lesions, relapses and worsening of disability). In patients with PPMS, ocrelizumab helps to slow down the progression of the disease and reduces deterioration in walking speed.

Shirley Hopper, Deputy Director of Innovative Medicines, said:

"Enabling safe access to high quality, safe and effective medical products are key priorities for us.

"We’re assured that the appropriate regulatory standards of safety, quality and effectiveness for the approval of this new formulation have been met.

"As with all products, we will keep its safety under close review."

Ocrelizumab injection was compared to ocrelizumab infusion in a randomised study of 236 patients with either RMS or PPMS. Patients received a 920 mg injection as a single dose, or a 600 mg infusion split into 2 doses separated by 2 weeks. Over 12 weeks from the injection or first infusion, the drug levels in the blood were similar for the injection and infusion formulations.

The most common side effect of ocrelizumab treatment given as a subcutaneous injection is an injection reaction, which may affect more than 1 in 10 people. Patients taking this treatment may also get infections more easily, including the flu, sinus infections, bronchitis, herpes infection, infection of the stomach and bowel, respiratory tract infection, viral infection and skin infection.

As with any medicine, the MHRA will keep the safety and effectiveness of ocrelizumab under close review. Anyone who suspects they are having a side effect from this medicine is encouraged to talk to their doctor, pharmacist or nurse and report it directly to the Yellow Card scheme, either through the website (https://yellowcard.mhra.gov.uk) or by searching the Google Play or Apple App stores for MHRA Yellow Card.

ENDS

Notes to Editors

- The new marketing authorisation was granted on 09 July 2024 to Roche.

-More information can be found in the Summary of Product Characteristics and Patient Information leaflets which will be published on the MHRA Products website within 7 days of approval.

- For more information about MS visit: https://www.nhs.uk/conditions/multiple-sclerosis

- The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.

- The MHRA is an executive agency of the Department of Health and Social Care.

- For media enquiries, please contact the newscentre@mhra.gov.uk, or call on 020 3080 7651.

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