Green light for 12 new medicines from EU watchdog

Written by | 8 Apr 2024 | Legislative and Regulatory

The European Medicines Agency (EMA) has recommended the approval of twelve new products, following reviews by its key human medicines committee (CHMP). This brings to twenty-five the number of newly approved medicines in 2024.

The CHMP backed the granting of marketing authorisation for:

Awiqli (insulin icodec) for the treatment of diabetes mellitus in adults.

Emblaveo (aztreonam-avibactam), an antibiotic indicated for the treatment of complicated intra-abdominal and urinary tract infections, hospital-acquired pneumonia and infections caused by certain types of bacteria (aerobic Gram-negative) that are resistant to many currently available antibiotics and where patients have limited or sometimes no treatment options.

Fabhalta (iptacopan), an oral treatment for adults with paroxysmal nocturnal haemoglobinuria, a rare genetic disorder and potentially life-threatening blood disease leading to the premature destruction of red blood cells by the immune system.

Lytenava (bevacizumab), for the treatment of neovascular age-related macular degeneration, a progressive retinal macular disease which causes gradual vision impairment mainly in the elderly.

Jubbonti (denosumab), for the treatment of osteoporosis and bone loss.

Omlyclo (omalizumab), for the treatment of asthma, severe chronic rhinosinusitis with nasal polyps, and chronic spontaneous urticaria.

Wyost (denosumab), for the prevention of skeletal related events with advanced malignancies.

Agilus (dantrolene sodium, hemiheptahydrate), for the treatment of malignant hyperthermia, a life-threatening emergency condition in which the skeletal muscles of the body are over-stimulated and are unable to relax.

Neoatricon (dopamine hydrochloride), for the treatment of hypotension in neonates, infants and children.

Three generic medicines also received a positive opinion from the committee: Dimethyl fumarate Accord (dimethyl fumarate), Dimethyl fumarate Mylan (dimethyl fumarate) and Dimethyl fumarate Neuraxpharm (dimethyl fumarate). All three medicines are indicated for the treatment of adult and paediatric patients aged 13 years and older with relapsing remitting multiple sclerosis, a disease of the brain and spinal cord in which inflammation destroys the protective covering around nerves and the nerves themselves.

The committee also recommended extensions of indication for six medicines that are already authorised in the European Union (EU): BimzelxNilemdoNustendiOnivyde pegylated liposomal*Retsevmo and Xtandi.

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