Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 24-27 June 2024

EMA’s human medicines committee (CHMP) recommended ten medicines for approval at its June 2024 meeting. The committee recommended granting a marketing authorisation for Balversa (erdafitinib), for the treatment of adult patients with unresectable or metastatic urothelial carcinoma, a cancer of the bladder and urinary system. The CHMP adopted a positive opinion for Eurneffy (epinephrine), the first emergency treatment against allergic reactions that is administered as a nasal spray, not as an injection. See more details in the news announcement in the grid below.m Resvia (Respiratory Syncytial Virus (RSV) m RNA vaccine) received a positive opinion from the CHMP for prevention in adults 60 years of age and older of lower respiratory tract disease and acute respiratory disease caused by respiratory syncytial virus, a common respiratory virus that usually causes mild, cold-like symptoms but can lead to serious consequences in older adults. This is the first m RNA vaccine targeting a different pathogen than SARS-Co V-2 that receives a positive opinion from the CHMP. The committee recommended granting a conditional marketing authorisation for Ordspono* (odronextamab), for the treatment of follicular lymphoma and diffuse large B-cell lymphoma, two types of blood cancer that affect the immune system. Piasky (crovalimab) received a positive opinion from the CHMP for the treatment of paroxysmal nocturnal haemoglobinuria, a rare genetic disorder that causes the premature breakdown of...