Medicines Healthcare Products Regulatory Agency
Generalised myasthenia gravis (gMG) is a rare, long-term condition that causes muscle weakness. It most commonly affects the muscles that control the eyes and eyelids, facial expressions, chewing, swallowing and speaking, but can then spread to other muscle groups in the body.
Julian Beach, MHRA Interim Executive Director, Healthcare Quality and Access, said:
Patient safety is always our priority, which means enabling their access to high quality, safe and effective medical products.
Were assured that the appropriate regulatory standards for the approval of this medicine have been met.
As with all products, we will keep its safety under close review.
In myasthenia gravis, an immune system protein called IgG antibody triggers the immune system to damage the communication between nerves and muscles. Rozanolixizumab is a monoclonal antibody (a type of protein) designed to attach to FcRn, a protein that keeps IgG antibodies in the body for longer.
By binding to and blocking FcRn, the medicine supports the removal of IgG antibodies, thereby preventing them from damage the communication between nerves and muscles. This is expected to lead to an improvement in muscle function.
Rozanolixizumab is administered by a doctor or nurse as an infusion under the skin, usually in the lower part of the tummy, below the belly button. Each administration is done using an infusion pump, with patients receiving one infusion per week for six weeks.
A main study has shown that rozanolixizumab was effective in the treatment of adults with myasthenia gravis.
The study involved 200 adults (N= 67 placebo, N=66; 7mg/kg treatment group, N=67; 10mg/kg treatment group) with moderate to severe myasthenia gravis who received either rozanolixizumab at one of two doses (a low dose and a higher dose) or placebo (a dummy treatment).
The study looked at the effect of treatment using a myasthenia gravis?specific activities of daily living (MG?ADL) scale which measures the impact of the disease on patients daily activities. The scale ranges from 0 to 24 and higher scores indicate more severe symptoms.
After one 6-week treatment cycle, patients treated with rozanolixizumab at either dose had a reduction of around 3.4 points in their MG?ADL scores compared with around 0.8 points for patients treated with placebo.
The most common side effects of the medicine(which may affect more than 1 in 10 people) include headache (including migraines), diarrhoea, and fever.
As with any medicine, the MHRA will keep the safety and effectiveness of rozanolixizumab under close review. Anyone who suspects they are having a side effect from this medicine are encouraged to talk to their doctor, pharmacist or nurse and report it directly to the MHRA 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.
Notes to editors?
- The new marketing authorisation was granted on 7 March 2024 to UCB Pharma Ltd.
- 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.
- The main study was randomised, double-blinded and placebo-controlled. A double-blind study is where neither the participants nor the staff on the trial were aware of which patients were given the treatment, in this case rozanolixizumab or the placebo. For more information about the study, see the Summary of Product Characteristics.
- For more information about myasthenia gravis, visit: https://www.nhs.uk/conditions/myasthenia-gravis/
- 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 cal