At its March meeting, the EMA’s key committee on human medicines (CHMP) approved nine new products:

• Bimervaxas a booster for people aged 16 years and older who have previously been vaccinated with a mRNA COVID-19 vaccine. It is the eighth vaccine recommended in the European Union (EU) for protecting against COVID-19.
• Briumvi(ublituximab) for the treatment of relapsing multiple sclerosis, a disease of the brain and spinal cord in which inflammation destroys the protective covering around nerves and the nerve themselves.
• Omvoh(mirikizumab) for the treatment of moderately to severely active ulcerative colitis, an inflammation of the large intestine causing ulceration and bleeding.
• Pedmarqsi(sodium thiosulfate) for the prevention of ototoxicity induced by cisplatin chemotherapy in patients from one month up to 18 years of age with localised, non-metastatic, solid tumours.
• Epysqli(eculizumab), a biosimilar medicine for the treatment of paroxysmal nocturnal haemoglobinuria, a rare disorder that leads to the premature destruction and impaired production of blood cells.
• Qaialdo(spironolactone) for the management of refractory oedema, a persistent swelling which does not respond to the use of diuretics and sodium restriction.
• Dabigatran Etexilate Accord(dabigatran etexilate) for the prevention of venous thromboembolic events.
• Lacosamide Adroiq(lacosamide) for the treatment of epilepsy.
• Sugammadex Adroiq(sugammadex) for the reversal of neuromuscular blockade induced by rocuronium or vecuronium.

This brings to 21 the total number of new medicines approved in the first quarter of 2023.