European Medicines Agency accepts six new medicines in April meeting
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.
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