The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), which authorizes and monitors medicines marketed in the EU, recommended, during the March session, 12 medicines for approval.
12 new drugs have received a recommendation for authorization from the EMA, archive photo
The list of the 12 medicines that are to be approved and, subsequently, enter the markets in the European Union, as well as those that are still under debate, was published on the official website of the European Medicines Agency, EMA.
In the context in which doctors have warned that after Covid there are more and more cases of infections caused by certain types of bacteria resistant to most drugs on the market, the CHMP list includes Emblaveo (aztreonam-avibactam), an antibiotic that could meet the needs current.
Diabetes patients could also benefit from the granting of a marketing authorization for Awiqli, an icodec insulin for adults.
The drug Fabhalta, also on the list, is intended for adults with paroxysmal nocturnal hemoglobinuria, a rare genetic disorder and blood disease that can be life-threatening through the premature destruction of red blood cells by the immune system.
Lytenava (bevacizumab) received a positive opinion from the CHMP for the treatment of neovascular age-related macular degeneration, a progressive macular disease of the retina that causes gradual deterioration of vision, mainly in older people.
Medicines that received the recommendation
Awiqli (icodec insulin), for the treatment of diabetes in adults.
Emblaveo (aztreonam-avibactam), a new antibiotic against antibiotic-resistant infections.
Fabhalta (iptacopan)an oral treatment for adults with paroxysmal nocturnal hemoglobinuria.
Lytenava (bevacizumab)for the treatment of patients with age-related macular degeneration, the neovascular form.
Jubbonti (denosumab), biosimilar, for the treatment of osteoporosis.
Omlyclo (omalizumab), biosimilar, for the treatment of patients with asthma and chronic rhinosinusitis.
Wyost (denosumab), for the prevention of bone manifestations in patients with advanced malignant tumors.
Agilus (dantrolene sodium, hemiheptahydrate)for the treatment of malignant hyperthermia.
Neoatricone (dopamine hydrochloride)for the treatment of arterial hypotension in newborns, infants and children.
Dimethyl fumarate Accord, Dimethyl fumarate Mylan and Dimethyl fumarate Neuraxpharm (dimethyl fumarate), generic drugs, for the treatment of patients with multiple sclerosis, relapsing-remitting form.
The CHMP also recommended the extension of therapeutic indications for six drugs: Bimzelx, Nilemdo, Nustendi, Onivyde pegylated liposomal, Retsevmo and Xtandi.
