From their meeting in April, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has published the highlights.
At this meeting there were three recommendations for approvals of medicines, including one generic medicine. One hybrid medicine, named Dzuveo (sufentanil), received a positive opinion for the treatment of pain. Hybrid applications rely partly on the results of pre-clinical tests and clinical trials for a reference product, and partly on new data.
The applicants for Dexxience (betrixaban) and Eladynos (abaloparatide) have requested re-examinations of the CHMP’s negative opinions for these medicines adopted at the March 2018 meeting. The application for an initial marketing authorisation for Prohippur (sodium benzoate) was withdrawn. This medicine was intended to be used for the treatment of non-ketotic hyperglycinaemia and urea cycle disorders. There were also eight recommendations on extensions of therapeutic indication.
For the meeting summary, and a full list of approvals, opinions and withdrawals, please click here.