News

Under-the-skin efgartigimod wins approval in UK for gMG adults

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…

Sustained gains with long-term Vyvgart use seen in ADAPT+ trial

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…

MG flares affect sizable number of patients in US, despite treatment

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…

Use of under-the-skin efgartigimod now approved for gMG in Japan

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 tolerated well in preclinical study

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…

Serum fibrinogen may be a universal biomarker for MG: Study

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…

Rystiggo, Zilbrysq earn EU approvals for adults with gMG

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.