Seven new medicines recommended for approval

EMA’s human medicines committee (CHMP) recommended seven medicines for approval at its April 2023 meeting.

The CHMP recommended granting a marketing authorisation for Arexvy (recombinant, adjuvanted), the first vaccine for active immunisation to protect adults aged 60 years and older against lower respiratory tract disease caused by respiratory syncytial virus (RSV). RSV is a common respiratory virus that usually causes mild, cold-like symptoms that can be serious in vulnerable people, including older adults and those with lung or heart disease and diabetes. See more information in the news announcement in the grid below.

The Committee gave a positive opinion for Camzyos (mavacamten) for the treatment of symptomatic obstructive hypertrophic cardiomyopathy, a disease in which the heart muscle becomes thickened and can make it harder for the heart to pump blood.

A positive opinion was adopted for Columvi* (glofitamab) under conditional…