MHRA approves Rystiggo for myasthenia gravis

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has today approved Rystiggo (rozanolixizumab), from Belgium’s largest drug maker UCB (Euronext: UCB), to treat adults with generalized myasthenia gravis, an autoimmune disease that causes muscle weakness, which can affect multiple muscle groups throughout the body.

Rystiggo won European Commission approval for myasthenia gravis in January this year, and has also been authorized in the USA and Japan. The product competes with argenx’ (Euronext: ARGX) Vyvgart (efgartigimod alfa), another antibody which has the same mechanism of action.

Julian Beach, MHRA  interim executive director, Healthcare Quality and Access, said: “Patient safety is always our priority, which means enabling their access to high quality, safe and effective medical products. We’re assured that the appropriate regulatory standards for the approval of this medicine have been met.”