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Generalised myasthenia gravis (gMG)

Late-stage trial boost for Argenx’s myasthenia gravis drug Vyvgart

26 August 2025 | By Catherine Eckford (European Pharmaceutical Review)

The Phase III findings could represent a critical advancement in managing the rare autoimmune disease in those with limited treatment options.

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Innovative biologic for myasthenia gravis granted European approval

8 January 2024 | By Catherine Eckford (European Pharmaceutical Review)

The biologic is approved based on Phase III study data in generalised myasthenia gravis (gMG), which demonstrated that rozanolixizumab facilitated statistically significant improvements in gMG-specific outcomes compared to placebo.

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Novel generalised myasthenia gravis treatment approved

4 December 2023 | By Catherine Eckford (European Pharmaceutical Review)

A subcutaneous C5 complement inhibitor has been authorised by the European Commission (EC) as a treatment for generalised myasthenia gravis in Europe.

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CHMP’s September 2023 meeting highlights

18 September 2023 | By Catherine Eckford (European Pharmaceutical Review)

In its September 2023 meeting, the EMA’s human medicines committee (CHMP) recommended nine medicines for approval and the extension of therapeutic indications for 11 medicines.

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Approval expanded for generalised myasthenia gravis medicine

27 July 2023 | By Catherine Eckford (European Pharmaceutical Review)

Extended EU approval of Soliris to paediatric generalised myasthenia gravis (gMG) patients is based on Phase III data which demonstrated improvement in disease severity through 26 weeks.

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First RNA CAR-T therapy autoimmunity trial shows potential

23 June 2023 | By Catherine Eckford (European Pharmaceutical Review)

A novel RNA CAR-T cell therapy demonstrated long-term clinical benefit for most generalised myasthenia gravis (gMG) patients in a landmark study.

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First FcRn blocker approved in UK for myasthenia gravis

17 March 2023 | By Catherine Eckford (European Pharmaceutical Review)

VYVGART (efgartigimod alfa-fcab) has been approved for adults with generalised myasthenia gravis by UK Medicines and Healthcare products Regulatory Agency (MHRA).

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Ultomiris for generalised myasthenia gravis

26 September 2022 | By Catherine Eckford (European Pharmaceutical Review)

The first and only long-acting C5 inhibitor, Ultomiris (ravulizumab), has been permitted in Europe for adults with generalised myasthenia gravis.

Empty wheelchair facing out towards a street - idea of disability or disorders such as myasthenia gravis that may leave people immobile

news

Ultomiris of long-term clinical benefit in myasthenia gravis patients

8 April 2022 | By Hannah Balfour (European Pharmaceutical Review)

New Ultomiris (ravulizumab-cwvz) follow-up data shows sustained functional improvements in certain adults with generalised myasthenia gravis (gMG).

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Generalised myasthenia gravis (gMG)