An under-the-skin, or subcutaneous, injectable formulation of efgartigimod alfa has been approved in the U.K. as an add-on therapy for adults with generalized myasthenia gravis (gMG) who test positive for antibodies against the acetylcholine receptor (AChR). This new formulation will be marketed in the U.K. as Subcutaneous Vyvgart. In…
Nipocalimab, an investigational therapy for people with generalized myasthenia gravis (gMG), significantly eased disease severity compared with a placebo, according to top-line data from a pivotal Phase 3 clinical trial. Johnson & Johnson, the therapy’s developer, also plans to engage with regulatory authorities worldwide to present…
Both high-dose intravenous methylprednisolone (IVMP) and tacrolimus effectively reduced symptom severity in patients with ocular myasthenia gravis (OMG) who failed to respond to oral steroids, a study shows. IVMP began to work quickly and more patients on it achieved a clinically meaningful treatment response over six months. “Both IVMP…
Repeat cycles of Vyvgart (efgartigimod alfa-fcab) led to consistent clinical improvements among generalized myasthenia gravis (gMG) patients, regardless of whether they were positive for antibodies against the acetylcholine receptor, according to interim findings from the ADAPT+ extension study. Given the variability in how many treatment cycles each patient…
Despite treatment, people with myasthenia gravis (MG) in the U.S. continue to experience exacerbations — episodes of disease worsening that may require urgent treatment and hospitalization — that carry high clinical and economic costs. That’s according to a large retrospective analysis of claims data for patients with employer-based commercial…
An under-the-skin or subcutaneous injection formulation of efgartigimod has been approved in Japan for use by adults with generalized myasthenia gravis (gMG) who do not sufficiently respond to first-line treatment with steroids or non-steroidal immunosuppressive therapies. In Japan, the now-approved therapy — efgartigimod alfa and hyaluronidase-qvfc — will be…
TOL2, a medication being developed by Toleranzia for the treatment of myasthenia gravis (MG), was found to be well tolerated in a preclinical toxicology study, supporting the company’s decision to test it in humans. No side effects were observed when lab animals were given a dose of TOL2…
High levels of serum fibrinogen were found to be a sensitive and specific biomarker to identify people with myasthenia gravis (MG), according to a recent study. Fibrinogen is a plasma protein that participates in blood clotting and is usually not present in the serum. In MG patients, residual fibrinogen…
The European Commission has approved Rystiggo (rozanolixizumab) as an add-on to standard therapy for the treatment of certain adults with generalized myasthenia gravis (gMG), closely following its clearance of Zilbrysq (zilucoplan) as an add-on treatment last month. These medications are sold by the biopharma company UCB.
Treatment with the experimental cell therapy Descartes-08 led to reductions in disease severity that were sustained out to one year for five of seven generalized myasthenia gravis (gMG) patients taking part in a Phase 2a clinical trial. That’s according to new data, announced by the therapy’s developer Cartesian Therapeutics,…
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