LONDON, June 9 -- The government of the United Kingdom issued the following news:
The Medicines and Healthcare products Regulatory Agency (MHRA) has today (9June 2026)authorisedthe medicinenipocalimab(Imaavy)to treatadults and adolescents aged 12 years and older withgeneralised myasthenia gravis (gMG).
Myasthenia gravis isan autoimmune disease in which the immune system (the body's natural defences) disrupts communication between nerves and muscles, causing muscle weakness and tiredness.It most commonly affects the muscles that control the eyes and eyelids, facial expressions, chewing,swallowing,and speaking, but it can affect most parts of the body.
In patients withthe condition,immunoglobulin G (IgG)autoantibodies attack and damage certain proteins on the nerves called acetylcholine receptors. Because of this damage, the nervesare not able tomake the muscles contract as well as normal, leading to muscle weakness and difficulty moving.
Nipocalimabbinds to a protein in the body called the neonatal Fc receptor (FcRn). This binding reduces levels of IgG autoantibodies - immune system proteins that mistakenly attack the body's own tissues.By doing this, the medicine can improve the ability of muscles to contract and reduce the symptoms of the disease and their impact on daily activities.
Julian Beach, MHRA Executive Director, Healthcare Quality and Access, said:
"Myasthenia gravis can significantly affect a person's ability to carry out everyday activities, and today's authorisation provides an additional treatment option for adults and adolescents living with this condition.
"We haveassessed the evidence fornipocalimaband are satisfied it meets our standards for safety, quality and effectiveness. As with all authorised medicines, we will continue to monitor its safety closely."
Nipocalimabis given as an infusion (drip) into a vein every 2 weeks.
Thisauthorisationis supported by evidence from amain study of 153 adults withgMG,for whostandard treatmentwas insufficient,andasupportive study of 8 adolescents aged 12 to 17.
The most common side effects of the medicine (which may affect more than 1 in 10 people) includehigh level of lipids (fats) or cholesterol in the blood, decreases in the level of 'albumin' (a protein) in the blood, muscle spasms, and swollen hands, ankles or feet (peripheral oedema).For the full list of side effects, see the package leaflet.
As with any medicine, the MHRA will keep the safety and effectiveness ofnipocalimabunder 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 Yellow Card scheme, either through thewebsite(https://yellowcard.mhra.gov.uk/) or by searching the Google Play or Apple App stores for MHRA Yellow Card.
Notes to editors
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Thenew marketingauthorisation was granted on9June2026toJanssen-Cilag Limited.
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This application was approved under theInternational Recognition procedure (IRP).
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More information can be found in the Summary of Product Characteristics and Patient Information leaflets which will be published on theMHRA Products websitewithin 7 days of approval.
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For more information aboutMyasthenia gravis, visit:Myasthenia gravis - NHS
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The Medicines and Healthcare products Regulatory Agency (MHRA)is responsible forregulating 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.
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The MHRA is an executive agency of the Department of Health and Social Care.
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For media enquiries, please contact thenewscentre@mhra.gov.uk, or call on 020 3080 7651.
Disclaimer: Curated by HT Syndication.
