EMA's CHMP backs a massive 10 novel drug for approval

The European Medicines Agency’s (EMA) human medicines committee (CHMP) recommended 1o novel medicines, as well as some biosimilars and indication extensions, for approval at its July 2023 meeting.

The CHMP recommended granting a marketing authorization for Pfizer’s (NYSE: PFE) Abrysvo (bivalent, recombinant), a vaccine to protect against disease caused by the respiratory syncytial virus (RSV). Abrysvo is the first RSV vaccine indicated for passive immunization of infants from birth through six months of age following administration of the vaccine to the mother during pregnancy. It is also indicated for active immunization of adults aged 60 years and older.

The Committee gave a positive opinion for Apretude (cabotegravir), from ViiV Healthcare, 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.