Researchers have identified a previously unrecognised immune environment in the thymus that may help explain why myasthenia gravis (MG) persists in some patients despite treatment. The findings provide new insights into the biology of the autoimmune disease and could point towards future therapeutic targets. Published in Science Advances, the Northwestern Medicine study combined single-cell RNA…
Category: Myasthenia Gravis
Pregnancy not linked to increased myasthenia gravis flare-ups, study finds
Pregnancy does not appear to increase the risk of serious disease flare-ups for most women with myasthenia gravis, according to a new study published in American Academy of Neurology journal Neurology. Researchers found that while a small proportion of patients experienced worsening symptoms after giving birth, pregnancy itself was not associated with a greater likelihood…
Efgartigimod approved for seronegative myasthenia gravis patients
The US Food and Drug Administration has expanded approval of efgartigimod alfa-fcab, marketed as Vyvgart, to include adults with acetylcholine receptor antibody (AChR-Ab) seronegative generalised Myasthenia gravis. The decision makes it the first FcRn-targeted therapy approved for this previously underserved patient group. The updated licence means the treatment can now be prescribed to all adult…
CHMP backs new zilucoplan pre-filled pen for myasthenia gravis in Europe
UCB has received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use supporting a new pre-filled pen device for zilucoplan, offering an additional treatment delivery option for adults with generalised myasthenia gravis. The recommendation covers the use of the zilucoplan pre-filled pen as an add on to standard therapy…
CHMP backs expanded indications for Uplizna in NMOSD, IgG4-RD and gMG
The Committee for Medicinal Products for Human Use has adopted a positive opinion recommending an extension to the marketing authorisation for Uplizna, also known as inebilizumab, broadening its use across three immune-mediated neurological and systemic conditions. The opinion, adopted on 11 December 2025, supports new indications for Uplizna in neuromyelitis optica spectrum disorders, immunoglobulin G4-related…
FcRn blocker Imaavy approved by FDA
First and only FcRn blocker approved in anti-AChR and anti-MuSK antibody positive adults and pediatric gMG patients aged 12 and older Johnson & Johnson announced on April 30th 2025 that the U.S. Food and Drug Administration (FDA) has approved IMAAVY™ (nipocalimab-aahu), a human FcRn-blocking monoclonal antibody, for the treatment of generalised myasthenia gravis (gMG). The…
First patient dosed in Phase 3 study of oral cladribine in gMG
29 August, 2024: Merck has announced the first patient has been dosed in the Phase III MyClad trial (NCT06463587) evaluating the efficacy and safety of oral cladribine for the treatment of generalized Myasthenia Gravis (gMG). Cladribine capsules have the potential to be the first oral treatment for gMG patients. gMG is a rare, neuromuscular disorder…
RYSTIGGO®▼ (rozanolixizumab) EC approval
UCB announces European Commission approval of RYSTIGGO®▼ (rozanolixizumab) for the treatment of adults with generalized myasthenia gravis in Europe 8th January 2024: UCB, a global biopharmaceutical company, today announced that the European Commission (EC) granted a marketing authorisation for RYSTIGGO® (rozanolixizumab) on 5th January 2024 as an add-on to standard therapy for the treatment of…
EC approves adult generalised Myasthenia gravis treatment
UCB announces European Commission approval of ZILBRYSQ[®]▼ (zilucoplan) 4th December, 2023: UCB, a global biopharmaceutical company, today announced that the European Commission (EC) has granted a marketing authorisation for ZILBRYSQ® (zilucoplan) as an add-on to standard therapy for the treatment of generalised myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody-positive.1 Zilucoplan is the…
New treatment for myasthenia gravis
UCB receives CHMP positive opinion for rozanolixizumab for treatment of adults with generalized myasthenia gravis in Europe 10th November 2023; UCB announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending granting marketing authorisation for rozanolixizumab as an add-on to standard therapy…
