The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has accepted six new medicines at its April meeting.
- Zavicefta Ceftazidime/avibactam (Zavicefta), a new treatment option against multi-drug resistant bacteria. The medicine is to be used in adult patients with intra-abdominal infection, urinary tract infection, as well as pneumonia acquired in a hospital setting. It is also indicated for the treatment of adults with infections caused by certain Gram-negative bacteria, for which there are only limited treatment options
- Daclizumab (Zinbryta) for the treatment of relapsing forms of multiple sclerosis
- Opicapone (Ongentys) for the treatment of Parkinson’s disease and motor fluctuations
- Emtricitabine/rilpivirine/tenofovir alafenamide (Odefsey) for the treatment of human immunodeficiency virus type 1 (HIV-1) infection
- Pancreas powder (Enzepi) for the treatment of exocrine pancreatic insufficiency
- Lutetium (177 lu) chloride (EndolucinBeta), a radiopharmaceutical precursor that has to be combined with another medicine, a carrier medicine, in a process called radiolabelling before administration. The carrier medicine then takes EndolucinBeta to the disease site in the body where it gives off beta-radiation, allowing a localised radiation effect.
Additionally, a positive scientific opinion was given to chlorhexidine digluconate (Umbipro), an antiseptic gel to prevent umbilical cord infections (omphalitis) in new-born babies.
The EMA issued a negative opinion for glycopyrronium bromide (Sialanar), which was intended for the treatment of persistent drooling in children and adolescents with neurological conditions.