14 new medicines recommended for approval
EMA’s human medicines committee (CHMP) recommended 14 medicines for approval at its July 2023 meeting.
The CHMP recommended granting a marketing authorisation for Abrysvo (bivalent, recombinant), a vaccine to protect small infants and older people 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 details in the news announcement in the grid below.
The Committee gave a positive opinion for Apretude (cabotegravir) for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired human immunodeficiency virus type 1 (HIV-1) infection. According to the World Health Organization (WHO), 39 million people were living with HIV worldwide at the end of 2022.
A positive opinion was adopted for Degarelix Accord (degarelix acetate), a generic medicine for the treatment of prostate cancer…
