News

Intravenous Vyvgart resolves MG crisis: Case study

Intravenous (into-the-vein) treatment with Argenx’s Vyvgart (efgartigimod alfa) resolved a myasthenic crisis — a life-threatening complication of myasthenia gravis (MG) marked by severe breathing problems — in a 57-year-old man who had failed to respond to prior treatments, according to a case study. The findings…

Zilbrysq now approved in Canada to treat adults with generalized MG

UCB’s injection therapy Zilbrysq (zilucoplan) has gained approval in Canada for treating adults with generalized myasthenia gravis (gMG) who are positive for antibodies targeting the acetylcholine receptor (AChR). The decision by Health Canada was supported by results from the Phase 3 RAISE trial (NCT04115293), in which the…

Under-the-skin efgartigimod now approved in China to treat gMG

An under-the-skin, or subcutaneous, injectable form of efgartigimod alfa has been approved in China to treat adults with generalized myasthenia gravis (gMG) who test positive for antibodies against the acetylcholine receptor. The therapy was approved as an add-on to standard gMG treatment. This subcutaneous formulation of efgartigimod (efgartigimod…

Puberty hormones may fuel thymus enlargement in MG girls: Study

Adolescent girls with juvenile myasthenia gravis (JMG) were more likely to have enlarged thymus glands than younger girls and adults with myasthenia gravis (MG), according to a retrospective study in France. The higher levels of female hormones during puberty may explain these results, the researchers noted, supporting the potential…

New Phase 3 trial data support efficacy of nipocalimab in gMG

Treatment with nipocalimab led to significant reductions in disease severity among people with generalized myasthenia gravis (gMG), as assessed by a drop in the MG Activities of Daily Living (MG-ADL) score, according to top-line data from a pivotal Phase 3 trial. Findings from the trial, dubbed VIVACITY-MG3…

Harbour BioMed resubmits request for batoclimab approval in China

Harbour BioMed has submitted a new, revised version of a biologics license application (BLA) to China’s regulatory agency requesting the approval of batoclimab (HBM9161) to treat generalized myasthenia gravis (MG). The original application was accepted for review last year by China’s National Medical Products Administration (NMPA). The…