Nine new medicines recommended for approval
EMA’s human medicines committee (CHMP) recommended nine medicines for approval at its March 2023 meeting.
The CHMP recommended authorising the COVID-19 vaccine Bimervax (previously COVID-19 Vaccine HIPRA) as a booster in 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 and, together with the vaccines already authorised, will support vaccination campaigns in EU Member States during the pandemic. An overview of all the COVID-19 vaccines authorised in the EU is available on EMA’s website.
The committee adopted a positive opinion for 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) received a positive opinion from the CHMP for the treatment of moderately to severely active ulcerative colitis, an inflammation of the large intestine causing ulceration and bleeding.
The committee recommended granting a paediatric-use marketing authorisation (PUMA) for Pedmarqsi (sodium thiosulfate) for the prevention of ototoxicity induced by cisplatin chemotherapy. Ototoxicity is the development of hearing or balance problems due to a medicine and Cisplatin is a chemotherapy used to treat several types of cancer. Pedmarqsi is indicated in patients from one month up to 18 years of age with localised, non-metastatic, solid tumours.
The committee adopted a positive opinion for 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.
The CHMP gave a positive opinion to Qaialdo (spironolactone) for the management of refractory oedema, a persistent swelling which does not respond to the use of diuretics and sodium restriction. This medicine was submitted as a hybrid application, which relies in part on the results of pre-clinical tests and clinical trials of an already authorised reference product and in part on new data.
The committee adopted positive opinions for three generic medicines:
- 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.
Recommendations on extensions of therapeutic indication for six medicines
The committee recommended six extensions of indication for medicines that are already authorised in the EU: Breyanzi, Entresto and its duplicate Neparvis, Tenkasi, Ultomiris and Wegovy.
For Ultomiris, the committee also recommended a new route of administration with a new strength and pharmaceutical form.
Withdrawals of applications
Three applications for marketing authorisation were withdrawn:
- Feraheme, intended for the intravenous treatment of iron deficiency anaemia.
- Onteeo, intended for the treatment of rheumatoid arthritis, active systemic juvenile idiopathic arthritis, juvenile idiopathic polyarthritis, giant cell arteritis, treatment of rheumatoid arthritis, active systemic juvenile idiopathic arthritis, juvenile idiopathic polyarthritis, and COVID-19.
- Raltegravir Viatris, intended for the treatment of human immunodeficiency virus (HIV-1) infection.
Onteeo is a duplicate of a medicine which is currently under evaluation.
Agenda and minutes
The agenda of the March 2023 CHMP meeting is published on EMA’s website. Minutes of the February 2023 CHMP meeting will be published in the coming weeks.